RFG Plus Model RFG2 Operating Instructions Rev B

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Table of Contents

Introduction... 1 Intended Use... 1 Unpacking and Inspection of Components... 1 Labeling Symbols... 2 Front Panel... 3 Indicators... 3 LCD Screen – ClosureFAST... 4 LCD Screen – ClosurePlus, ClosureRFS and ClosurePlex... 5 Gauges – ClosureFAST... 6 Gauges – ClosurePlus, ClosureRFS and ClosurePlex... 7 Rear Panel... 8 Instructions for Use... 9 Setup and Installation... 9 AC Power... 9 Changing Settings... 9 Connecting a Device... 10 RF Treatment - ClosureFAST... 12 RF Treatment - ClosurePlus, ClosureRFS and ClosurePlex... 14 Using MultiMediaCards (MMCs)... 16 Operating Modes... 18 Power On Self Test (POST) Mode... 18 Software Update Mode... 18 Identification Mode... 18 Measure Mode... 19 Saline Test Mode - ClosurePlus, ClosureRFS and ClosurePlex... 19 Body Test Mode - ClosurePlus, ClosureRFS and ClosurePlex... 19 Alarm Acknowledge Mode...20 Ready Mode - ClosureFAST... 20 RF Treatment Mode... 20 Error Mode... 20 RFG Setup Mode... 21 Device Setup Mode... 22 Troubleshooting... 23 Error Codes... 23 RF Treatment Difficulties... 27 Electromagnetic Interference (EMI)... 30 Technical Assistance... 31 Service and Maintenance... 31 Cleaning and Disinfection... 31 Fuse Replacement... 31 Warranty... 32 Repairs and Returns... 32 Disposal... 33 Technical Specifications... 33 Equipment Type... 33 Environmental Conditions... 33 RF Power Delivery Performance... 33 Accuracy... 34 Electrical... 34 Impedance and Power... 34 Mechanical Specifications... 34 Compliance... 34 General Safety Guidelines... 37 Precautions/Operation Warnings and Cautions... 38 RF Treatment Warnings and Cautions... 38 Glossary of Terms... 39

List of Figures Figure 1: Front Panel... 3 Figure 2: ClosureFAST Main Screen... 4 Figure 3: ClosurePlus, ClosureRFS and ClosurePlex Main Screen... 5 Figure 4: ClosureFAST Data Display With Gauges... 6 Figure 5: ClosurePlus, ClosureRFS and ClosurePlex Data Display with Gauges... 7 Figure 6: Gauge... 7 Figure 7: Rear Panel... 8 Figure 8: Connecting a Device... 10 Figure 9: ClosureFAST Measure Mode... 11 Figure 10: ClosurePlus, CClosureRFS or ClosurePlex Measure Mode... 11 Figure 11: ClosureFAST RF Treatment Started... 12 Figure 12: ClosurePlus, ClosureRFS and ClosurePlex RF Treatment Started... 15 Figure 13: ClosurePlus, ClosureRFS and ClosurePlex Advisory and Functional Limits... 16 Figure 14: Identification Mode... 19 Figure 15: Fuse Replacement... 32 Figure 16: Real Impedance v. RF Power Curve... 35 Figure 17: Impedance v. RF Power Curve (ClosureFAST)... 35 Figure 18: Impedance v. RF Power Curve (ClosurePlus)... 36 Figure 19: Impedance v. RF Power Curve (RFS)... 36 Figure 20: Peak Output Voltage v. Power... 37 Figure 21: Power Output v. Max Power Set Point... 37

List of Tables Table 1: Data Display Area Symbols and Icons... 2 Table 2: RF Generator Symbols and Icons... 2 Table 3: RF Power Button Status... 3 Table 4: Errors... 23 Table 5: RF Treatment Difficulties – ClosureFAST...27 Table 6: RF Treatment Difficulties - ClosurePlus, ClosureRFS, and ClosurePlex...29

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Introduction

Labeling Symbols

Prior to using the RF Generator, review the warnings and cautions in “General Safety Guidelines” of this manual for important safety information.

There are several symbols and icons used throughout this manual that are used by the RF Generator and its displays. The operator should be familiar with these symbols and their meanings. Table 1: Data Display Area Symbols and Icons

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.

Ω

Ohms (Impedance)

Information, Question, or Verification

The term “Device,” used throughout this manual, refers to compatible VNUS RF Devices that can be attached to the RF Generator.

°C

Degrees Celsius (Temperature)

Warning: Consult alarm/advisory message

W

Watts (Power)

Data Logging Indicator

OR

ClosureFAST icon: RF not actively powered

The VNUS RF Generator is for sale to and use under the supervision of physicians and is for prescription use only, as specified by 21 CFR 801.109(b) (1).

Intended Use

Please refer to the Instructions for Use included with the RF Device for information about clinical procedures. The VNUS RF Generator model RFG2 is intended for use with radiofrequency devices intended for vessel and tissue coagulation.

OR

ClosureFAST icon: RF actively powered to cause tissue heating

The RF Generator measures and displays RF output Power, load Impedance (not displayed for some devices), 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. Table 2: RF Generator Symbols and Icons

Caution: The VNUS RF Generator model RFG2 is compatible with VNUS RF Devices only. DO NOT use with Devices from any other manufacturer. Refer to the Device’s Instructions For Use for information related to the Device, such as cautions, warnings, precautions, potential complications, and contraindications.

Unpacking and Inspection of Components

AC Power ON

Non-Ionizing Radiation

AC Power OFF

Earth Ground

RF Power ON

MMC/SD Card

MultiMediaCard (MMC) Slot

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 AC Power cord without cracks, frays, or any visible cord or plug damage • CD-ROM containing this Operator’s Manual All damaged items must be repacked and returned to VNUS Customer Service Department with prior approval. See the “Repairs and Returns” section of this manual for more information about returning the unit.

RF Power OFF

Increment/UP

Attention: Consult accompanying documents

Decrement/DOWN

Fuses

Patient Isolated

Alternating Current

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Front Panel LCD screen

Increment/UP and Decrement/DOWN buttons

Treatment RF Power cannot be enabled until a Device is connected. RF Power button and indicator

Delivery Device receptacle AC Power Indicator Vent Slots

Soft Key Menu buttons

Figure 1: Front Panel

Audible Indicators The RF Generator has several audible indicators designed to alert the operator: • Alarm: Set of three rapid, high-frequency tones • Informational: Single short, low-frequency tone • Invalid: Single short, low-frequency tone • Power On: Three ascending-scale tones • RF Power On – Treatment: Two descending-scale tones • RF Power On – Alert: Two rapid groups of two high-frequency tones • RF Start: Single, long low-frequency tone • RF Stop: Single, long low-frequency tone • Valid: Single short, high-frequency tone

The RF Generator includes the following buttons on its front panel, as depicted in Figure 1: • Soft Key Menu: Activate the Soft Key Menus displayed directly above the buttons on the LCD display. • Increment/UP (▲) and Decrement/DOWN (▼): Cycle up or down through the available menu choices. After selecting a choice, press these buttons to increase, decrease, or toggle the value of that choice. • RF Power: Activates or deactivates RF Power.

Indicators

Each button press produces a valid or invalid tone. If a button fails to sound, this indicates button malfunction. Should a button malfunction, have the unit serviced.

LCD Screen – ClosureFAST The LCD screen consists of three areas: the Data Display area, Operator Message area, and Soft Key Menu area.

Visual Indicators

Data Logging indicator

Timer

Device ID

The RF Generator includes the following visual indicators, as depicted in Figure 1: • AC Power: Indicates when the RF Generator is turned on. • RF Power: Indicates RF Power status by changing color and illumination, as listed in Table 3. Table 3: RF Power Button Status Light

Color

Status

Mode

OFF

None

RF Power is disabled.

Identification or Measure

ON

Green

RF Power is enabled (ready for use).

Measure

ON

Flashing Green

RF Power is enabled, ready for a catheter or button press to activate RF treatment

Ready

ON

White

RF Power is activated (in use) and currently delivering RF Power.

RF Treatment

3

Data Display area

Gauges

VNUS Radio Frequency Generator

Operator Message area

Device Temperature

Progress Meter

RF Power

Soft Key Menu Area

Figure 2: ClosureFAST Main Screen Operating Instructions

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Data Display Area The Data Display area displays information about the RF Generator’s status. Depending on the status of the RF Generator, information in this area changes to show the following items: • Data Logging Indicator: Indicates that a MultiMediaCard (MMC) has been inserted and data is being logged. • Device ID: Indicates type of Device connected to the RF Generator. • Device Temperature: Indicates current Temperature of connected Device. • Gauges: Indicates Temperature and RF Power with an acceptable range shown for Temperature. • Timer: The timer counts down starting from the selected treatment time. • RF Power: Indicates current RF Power delivered to the Device.

LCD Screen – ClosurePlus, ClosureRFS and ClosurePlex Data Logging indicator

Timer

Gauges – ClosureFAST The RF Generator’s Data Display area includes colored gauges when a Device is connected. These gauges provide a quick and easy way to determine if the Device’s parameters (Temperature and RF Power) are within acceptable ranges. If a parameter is not within an expected range, the RF Generator displays an advisory message and sounds a tone. Upper Advisory Limit violated

Power Gauge with reference ticks at 10, 20, 30 and 40 Watts

Device ID

Gauge within normal range

Temperature Set Point

Data Display area

Gauges

Operator Message area

Device Temperature

Device Impedance

RF Power

Lower Advisory Limit violated

Operator Message

Soft Key Menu Area

Figure 3: ClosurePlus, ClosureRFS and ClosurePlex Main Screen

Data Display Area The Data Display area displays information about the RF Generator’s status. Depending on the status of the RF Generator, information in this area changes to show the following items: • Data Logging Indicator: Indicates that a MultiMediaCard (MMC) has been inserted and data is being logged. • Device ID: Indicates type of Device connected to the RF Generator. • Device Impedance: Indicates current Impedance of connected Device • Device Temperature: Indicates current Temperature of connected Device; it is not intended to measure patient body temperature. • Gauges: Indicates whether Temperature, Impedance, and RF Power are within or outside of preset limits. 5

• Timer: The functionality of the timer is device dependent. For ClosurePlus – Pullback Timer: Indicates the amount of time the Device has been pulled back during the current RF Power On cycle. For ClosureRFS or ClosurePlex – Treatment Timer: Indicates the amount of time RF Power has been delivered during the current RF Power On cycle. • RF Power: Indicates current RF Power delivered through the Device.

VNUS Radio Frequency Generator

Figure 4: ClosureFAST Data Display With Gauges The position of the Temperature gauge’s needle is based on the current value. It points to one of three colored areas, as described below: Green: Within normal range Red: Temperature above Advisory Limit Blue: Temperature below Advisory Limit The extent of illumination of the Power gauge is based on the current Power value. Green: Within normal range Red: Violation of Advisory Limits

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Gauges – ClosurePlus, ClosureRFS and ClosurePlex

Rear Panel

The RF Generator’s Data Display area includes colored gauges when a Device is connected and not in Measure Mode. These gauges provide a quick and easy way to determine if the Device’s parameters (Temperature, Impedance, and RF Power) are within acceptable ranges. If a parameter is not within an expected range, the RF Generator displays an advisory message and sounds a tone.

AC Power cord wrap

Handle Upper Advisory Limit violated

Fuse Holder

Gauge within normal range

AC Power Switch AC Power Inlet Quick Reference Card holder

Equipotential grounding lug

Vent Openings Gauge within normal range

Figure 7: Rear Panel The RF Generator includes these features, as depicted in Figure 7:

Operator Message

Figure 5: ClosurePlus, ClosureRFS and ClosurePlex Data Display with Gauges The position of the gauge’s needle is based on the current value of the corresponding parameter (Temperature, Impedance, or RF Power). It points to one of three colored areas, as described below: • Green: Within normal range • Yellow: Violation of Advisory Limits • Red: Violation of Functional Limits Red (lower)

Multimedia Service Memory Port Card (MMC) port

Yellow (lower)

Green

Yellow Red (upper) (upper)

• AC Power Switch: Turns on or off the RF Generator’s AC Power. • AC Power Cord Wrap: When the RF Generator is not in use, unplug the unit from the AC Power source and wrap the cord around the AC Power cord wrap area. • AC Power Inlet: Connects the AC Power cord to the RF Generator. • Equipotential Grounding Lug: Provides a point for an auxiliary Earth Ground connection. • Fuse Holder: Includes two 4A/250V, slo-blo, 5x20 mm fuses. • Handle: The RF Generator has a handle on each side. Use these handles while carrying or lifting the unit. • MultiMediaCard (MMC) Port: Accepts a MultiMediaCard (MMC) that can be used to store procedure data and to perform software upgrades. • Service Port: The RF Generator includes a USB port that is used for calibration and repairs. This port is for use by qualified service personnel only. • Vent Openings: The RF Generator includes vent openings on the rear panel. Do not block these openings.

Gauge needle

Figure 6: Gauge For more information about Advisory and Functional Limits, see the “Advisory and Functional Limits” section of this manual.

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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.

Setup and Installation

Caution: Allow at least 15 minutes after removing the RF Generator from a storage environment before turning on the unit. This lets the unit fully acclimate to the environment. Do not stack any items on top of the RF Generator. Doing so could damage the unit.

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 the 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.

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.

Français • 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 SELECT Soft 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 related Soft 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 ACCEPT Soft Key Menu button to save the choice as a default setting or press the CANCEL Soft Key Menu button to return to the previous screen without saving any changes. 6. After changing the desired setting(s), press the EXIT Soft Key Menu button to return to the RF Generator screen.

Connecting a Device To connect a Device, insert the Device’s connector into the receptacle on the RF Generator. If the Device does not have an integrated cable, use a VNUS-approved instrument cable. If the unit is turned on before a Device is attached, the RF Generator prompts the operator to connect a Device.

To turn on the RF Generator: 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 the unit.

Notice the small red dot at the top of the Device receptacle. This dot must be lined up with the small red mark and/or raised line on the Device connector being connected to 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

Device connector

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. The Soft Key Menu area displays related Soft Key Menus: • DEFAULTS: Returns all settings to the RF Generator’s factory defaults (except for Date, Time, and Language settings). 9 VNUS Radio Frequency Generator

Device cable

Device receptacle

Figure 8: Connecting a Device • When a Device is connected, the RF Generator’s LCD screen displays RF Treatment information, as shown in Figures 9 and 10.

Operating Instructions

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MEASURE MODE - ClosureFAST

RF Treatment - ClosureFAST

Data Logging indicator

Timer

Device ID

WARNING: Review this section and the “General Safety Guidelines” section of this manual before starting RF Treatment.

Before starting RF Treatment, review the Device’s Instructions For Use. Confirm that the connected Device matches the Device ID shown in the Data Display area.

Entering Ready Mode Press the RF Power button to enter Ready Mode. The RF Power button will change from non-illuminated to flashing green illumination.

Initiating RF Treatment Press the START RF button or the Device handle button to start RF Treatment. While delivering RF Power, the RF Power button illuminates white. The Device will increase to the set temperature and hold at that temperature until the treatment time has completed. After the treatment time has counted down to zero, RF Power delivery will stop automatically and the RF Power button will change to flashing green illumination to indicate Ready Mode. Pressing the START RF button or the Device handle button will start the next RF Treatment.

Soft Key Menu area

RF Power

Device Temperature

WARNING: Do not activate RF Power until the Device is properly positioned in the patient. Refer to the “General Safety Guidelines” section of this manual before starting RF Treatment.

Figure 9: ClosureFAST Measure Mode

Data Logging indicator

MEASURE MODE - ClosurePlus, ClosureRFS and ClosurePlex Data Logging indicator

Timer

Countdown Timer

Device ID

Device ID

Gauges during RF Treatment mode

Operator Message Area Soft Key Menu

Figure 11: ClosureFAST RF Treatment Started Soft Key Menu area Device Temperature

Device Impedance

RF Power

Temperature and Impedance must be within Functional Limits before RF Treatment can start. This temperature display is not intended to measure patient temperature but reflects Device temperature within a relative range.

Figure 10: ClosurePlus, ClosureRFS or ClosurePlex Measure Mode

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Advisory and Functional Limits

RF Treatment - ClosurePlus, ClosureRFS and ClosurePlex

While a Device is connected, the RF Generator monitors the Device’s parameters (Temperature, Impedance, and RF Power). Each parameter has a lower and upper Limit. Temperature and Impedance must be within Functional Limits before RF Treatment can start.

The Limits are determined by predefined settings for the connected Device. These limits can also be affected by Set Points that the operator defines in the Device Setup menu. See the “Device Setup Mode” section of this manual for information about defining Set Points. The Limits are monitored during RF treatment: • If the set temperature is not reached within a predetermined time, RF power will be stopped before the countdown has completed. This indicates a condition of poor contact between the Device and the tissue to be treated. • If the RF Generator detects that temperature is below the Limit, the gauge displays within the blue range. The unit sounds an Informational Tone and displays a message. • If the RF Generator detects that temperature is above the Limit, the gauge displays within the red range. The unit also: – Halts RF Treatment. – Sounds an Alarm Tone (for Temperature or RF Power parameters) or sounds an Informational Tone (for the Impedance parameter). – Enters Alarm Acknowledge Mode. – Displays an Alarm Message.

Halting RF Treatment During RF Delivery, press the STOP RF button or the Device handle button to halt RF Treatment (pressing the RF Power button will also halt RF Treatment and disable Ready mode). RF Treatment halts automatically if: • The time set for RF Treatment has elapsed (for Devices where RF Treatment time can be set). • A Functional Limit has been violated. • The RF Generator detects an error. • The Device is disconnected. Caution: If RF Treatment does not halt automatically, disconnect the Device.

Restarting RF Treatment

Before starting RF Treatment, review the Device’s Instructions For Use. Confirm that the connected Device matches the Device ID shown in the Data Display area. It is also highly recommended that the operator perform the optional Saline and Body Tests. These tests verify the accuracy of the Temperature and Impedance measurements of the Device. For information on performing the Saline Test and Body Test, refer to the “Saline Test Mode” and “Body Test Mode” sections of this manual. When the RF Generator and connected Device are ready to start RF Treatment, the RF Power button illuminates green. This indicates that Temperature and Impedance measurements are within the Functional range for the connected Device, and RF Treatment can start. Temperature and Impedance must be within Functional Limits before RF Treatment can start.

Initiating RF Treatment Press the RF Power button to start RF Treatment. While delivering RF Power, the RF Power button illuminates white. The following sequence starts automatically: 1. Vessel Heating • For Temperature Control Devices: Raises the Device Temperature to the Temperature Set Point. • For Power Control Devices: Raises the RF Power delivered to the Device to the Power Set Point. 2. Dwell Period • For Temperature Control Devices: Provides a prescribed heating period after the Device has reached Temperature Set Point. • For Power Control Devices: Provides a prescribed heating period after Device has reached Power Set Point. 3. RF Treatment • RF Treatment starts. • Timer starts.

The operator should correct any alarm condition before restarting RF Treatment. (See the “RF Treatment Difficulties” section of this manual for information about alarm conditions and corrective actions.)

WARNING: Review this section and the “General Safety Guidelines” section of this manual before starting RF Treatment.

WARNING: Do not activate RF Power until the Device is properly positioned in the patient. Refer to the “General Safety Guidelines” section of this manual before starting RF Treatment.

If the operator unplugs a Device and then reconnects a Device of the same model, the unit prompts the operator to either retain or discard the Timer Value. Press the YES or NO Soft Key Menu button to retain or discard, respectively, the sum of all times from all previous RF Power On cycles. If the unit has been turned off, a new Timer Value will start with the time reset to zero (0:00) when the unit is turned on again. The Total Treatment Time displays in the Operator Message area immediately after RF Power halts. 13

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Français Data Logging indicator

Français Lower Functional Limit violated

Device ID

Timer

Gauges during Saline Test and RF Treatment mode

Lower Advisory Limit violated

Upper Advisory Limit violated

Upper Functional Limit violated

Advisory Limits

Functional Limits

Figure 13: ClosurePlus, ClosureRFS and ClosurePlex Advisory and Functional Limits (As Displayed on a Parameter Gauge)

Operator Message Soft Key Menu commands

Figure 12: ClosurePlus, ClosureRFS and ClosurePlex RF Treatment Started

Dielectric Detection Some Devices support Dielectric Detection. This condition occurs when RF Power is not being delivered efficiently to the target tissue. During Dielectric Detection, an advisory message might appear in the Operator Message area stating, “Withdraw device 1–2 mm.” Once the Dielectric Detection condition has been resolved, the Vessel Heating and Dwell Period starts.

Advisory and Functional Limits While a Device is connected, the RF Generator monitors the Device’s parameters (Temperature, Impedance, and RF Power). Each parameter has a lower and upper Advisory Limit and a lower and upper Functional Limit. Temperature and Impedance must be within Functional Limits before RF Treatment can start. The Advisory and Functional Limits are determined by predefined settings for the connected Device. These limits can also be affected by Set Points that the operator defines in the Device Setup menu. See the “Device Setup Mode” section of this manual for information about defining Set Points. The range of Advisory Limits is within the range of Functional Limits: • If the RF Generator detects that a parameter violates Advisory Limits, the gauge displays within the yellow range. The unit sounds an Informational Tone and displays a message. • If the RF Generator detects that a parameter violates Functional Limits, the gauge displays within the red range. The unit also: – Halts RF Treatment. – Sounds an Alarm Tone (for Temperature or RF Power parameters) or sounds an Informational Tone (for the Impedance parameter). – Enters Alarm Acknowledge Mode. – Displays an Alarm Message.

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Halting RF Treatment During RF Delivery, press the RF Power button to halt RF Treatment. RF Treatment halts automatically if: • The time set for RF Treatment has elapsed (for Devices where RF Treatment time can be set). • A Functional Limit has been violated. • The RF Generator detects an error. • The Device is disconnected. Caution: If RF Treatment does not halt automatically, disconnect the Device.

Restarting RF Treatment The operator should correct any alarm condition before restarting RF Treatment. See the “RF Treatment Difficulties” section of this manual for information about alarm conditions and corrective actions. If the operator unplugs a Device and then reconnects a Device of the same model, the unit prompts the operator to either retain or discard the Timer Value. Press the YES or NO Soft Key Menu button to retain or discard, respectively, the sum of all times from all previous RF Power On cycles. If the unit has been turned off, a new Timer Value will start with the time reset to zero (0:00) when the unit is turned on again. The Total Pullback Time or Total Treatment Time displays in the Operator Message area immediately after RF Power halts. Total Pullback Time does not include Vessel Heating or Vessel Dwell times, while Total Treatment Time does.

Using MultiMediaCards (MMCs) MultiMediaCards (MMCs) can store data from recent procedures, log generator errors, and perform software updates. The operator must use SanDisk™ MultiMediaCards or compatible cards of sizes 16, 32, 64, or 128 megabytes (MB), VNUS part number MMC. Operating Instructions

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Updating Software The operator can perform software updates with a MultiMediaCard (MMC) that includes a VNUS RFG2 Memory Card Interface Protocol (MCIP) Update File. To update the software:

2. Place an MMC into the MMC port at the back of the unit. 3. Simultaneously press and hold the Increment/UP (▲) and Decrement/DOWN (▼) buttons, and then press the AC Power switch UP to turn on the unit. The RF Generator writes the Error Log file to the MMC, overwriting any existing Error Log files.

1. Press the AC Power switch DOWN to turn off the unit. 2. Remove the Data Collection MMC (if present) from the MMC port at the back of the unit. 3. Insert the Software Update MMC into the MMC port, pushing until it clicks into place. 4. Press the AC Power switch UP to turn on the unit.

Operating Modes

The RF Generator searches for an Update File. Once it finds an Update File, it verifies the update is valid according to the unit’s serial number.

Failure during any operating mode results in the RF Generator either not starting RF Treatment or automatically halting RF Treatment.

If a Software Update is not allowed due to inappropriate serial number, an advisory message displays. The RF Generator asks whether it should proceed with the software update. 5. Press the OK Soft Key Menu button to continue. The RF Generator proceeds to update its software from the MMC. The Data Display area shows the software update’s progress. When the software update has completed, the Data Display area indicates the operator may remove the MMC. If a Software Update fails, an advisory message indicates the error. 6. Remove the MMC from the MMC port. The RF Generator reboots. 7. Once the software update has successfully completed, reinsert the Data Collection MMC.

Collecting RF Treatment Data The Memory Card Interface Protocol (MCIP) Data File stores data from procedures, as well as indications of alarm occurrence, alerts, and errors. Logged RF Treatment data may be sent to VNUS RF Generator Support Department for troubleshooting. VNUS does not support using logged data for any other purpose. To collect RF Treatment Data, place the MultiMediaCard (MMC) in the MMC port either prior to turning on the unit or after connecting a Device. Data will not be collected until a Device has been connected. While the RF Generator logs data to the MMC, the Data Logging indicator appears in the upper left corner of the Data Display area. Data logging continues until the operator turns off the unit or removes the MMC from the MMC port. The MMC collects data while the operator has a Device connected, and stops when the operator disconnects the Device or turns off the unit. When the MMC is full, the oldest data log is deleted to make space for a new data log.

Power On Self Test (POST) Mode During the Power On Self Test (POST), the RF Generator performs a number of internal self-tests of its software: • Verifies integrity of system random access memory (RAM). • Verifies contents of program read-only memory (ROM). • Activates all visual indicators, including the LCD screen and the backlit Soft Key Menu buttons around the screen. • Sounds Power On tone. • Verifies operation of radiofrequency (RF) generation and measurement circuits. • Displays a notice if POST must restore the factory default settings due to a corruption of persistent settings, such as screen brightness or tone volume settings. Prior to using the RF Generator, observe that the screen, lights, and audible alarms cycle.

Caution: The RF Generator enters Error Mode if it detects a failure during the Power On Self Test (POST) Mode. If any error messages occur indicating that the RF Generator is not safe to use, power off the unit and contact VNUS.

Software Update Mode The Software Update Mode performs software updates if a MultiMediaCard (MMC) with software updates has been inserted into the MMC port. Once in Software Update Mode, the unit remains in this mode until the update completes and the operator removes the MMC from the MMC port. Read the “Using MultiMediaCards (MMCs)” section of this manual for more information about MMCs.

Identification Mode During Identification Mode, the RF Generator checks for a connected Device:

Collecting Error Logs Error Logs are descriptions of an error and the RF delivery data surrounding it. If a MultiMediaCard (MMC) was not already in the MMC Port when an error occurred, follow the procedure below to collect error logs: 1. Press the AC Power switch DOWN to turn off the unit. 17

The RF Generator has several operating modes. The operator must pay special attention to the Data Display area and Operator Message area during the Body Test, Saline Test, Measure, and RF Treatment modes, in which some level of RF Power is delivered.

• If no Device is connected, the Operator Message area asks the operator to “Please connect device.” • If the connected Device is unsupported, the Operator Message area says, “The connected device is unsupported. Please connect another device.” • If the connected Device is unknown or invalid, the Operator Message area says, “The device is invalid.” The Data Display area displays the current software version and the VNUS logo, as shown in Figure 14.

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Français • The measured Impedance and the expected Impedance range. • The measured Temperature and the expected Temperature range. When the Body Test has completed, the most recent Temperature and Impedance measurements display in the Operator Message area.

Data Display area

Press the Soft Key Menu button below a menu command to view or change settings.

Operator Message

For more information about Body Tests, view the Device’s clinical training materials.

Caution: If a Body Test indicates advisory conditions, this might indicate a faulty Device. Consult the Device’s Instructions for Use for more information.

Alarm Acknowledge Mode

Figure 14: Identification Mode

The Alarm Acknowledge Mode starts when RF Treatment halts due to an alarm or unrecoverable error. See the “RF Treatment Difficulties” section of this manual for information about unrecoverable errors. To end the Alarm Acknowledge Mode, press the OK Soft Key Menu button or wait 30 seconds for the mode to complete.

Measure Mode starts whenever a Device is attached to the RF Generator. During Measure Mode, the Data Display area displays the current parameters for the connected Device.

Once the Alarm Acknowledge Mode has completed, the RF Generator enters Measure Mode if a Device is connected or Identification Mode if a Device is not connected.

Measure Mode

While in Measure mode, violating Functional Limits results in an advisory message. The operator cannot start RF Treatment if the Device violates Functional Limits.

Caution: For ClosurePlus, ClosureRFS and ClosurePLEX the Measure, Saline Test, and Body Test modes use a small amount of RF energy (2.3 mW RMS) to measure Impedance at the Device tip. During these modes, output power is insufficient to cause tissue heating. However, the operator should be alert for interference to nearby equipment. For more information about interference, please consult the “Electromagnetic Interference (EMI)” section of this manual.

Saline Test Mode - ClosurePlus, ClosureRFS and ClosurePlex The Saline Test performs Temperature and Impedance measurements using 0.9% saline solution. When the operator presses the SALINE TEST Soft Key Menu button, the Saline Test displays for approximately 10 seconds before timing out. (Press the button again to restart the test.) The Saline Test displays the relationship between: • The measured Impedance and the expected Impedance range. • The measured Temperature and the expected Temperature. Values can vary due to actual saline temperature and should be verified before RF Treatment starts. For more information about Saline Tests, view the Device’s clinical training materials.

Caution: If a Saline Test indicates advisory conditions, this might indicate a faulty Device. Consult the Device’s Instructions for Use for more information.

Body Test Mode - ClosurePlus, ClosureRFS and ClosurePlex

Ready Mode - ClosureFAST Ready Mode starts after a ClosureFAST Device is attached to the RF Generator and the RF Power button is depressed as prompted on the screen. During Ready Mode, the Data Display area displays the current parameters for the connected Device. During Ready Mode, the RF Generator is enabled and will deliver RF power when the START RF button or the Device handle button is pressed.

RF Treatment Mode During the RF Treatment Mode, the RF Generator delivers RF Power. The RF Treatment Mode becomes active when the following are true: ClosurePlus, ClosureRFS, ClosurePlex: • Temperature and Impedance measurements are within Functional range for the connected Device. • The operator presses the RF Power button. ClosureFast: • Temperature and Impedance measurements are within Functional range for the connected Device. • The RF Power button has been pressed to enter ready mode. • The operator presses the START RF button or the Device handle button (note that if body temperature has not been measured, an alert will display; this alert can be cleared by pressing OK to proceed). When RF Treatment has completed, the RF Generator enters Measure Mode or Alarm Acknowledge Mode. For more information about RF Treatment, read the “RF Treatment” section of this manual.

The Body Test performs Temperature and Impedance measurements using the Device positioned in the patient for RF Treatment.

Error Mode

When the operator presses the BODY TEST Soft Key Menu button, the Body Test displays for approximately 15 seconds before timing out. (Press the button again to restart the test.) The Body Test displays the relationship between:

Error messages display when the RF Generator encounters an unrecoverable (unable to continue) error. The Error Mode becomes active and an error code or message displays if any of the following occurs:

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VNUS Radio Frequency Generator

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Gauges

• The RF Generator detects an unexpected internal error. • The Power On Self Test (POST) fails. When the Error Mode occurs, RF Treatment halts immediately and the RF Generator logs an entry in the Error Log. When an error message indicates a non-recoverable error has occurred, turn off the unit, wait a few seconds, and then turn on the unit. If an error persists, make a note of it and then contact the VNUS Technical Support Department or a local distributor.

RFG Setup Mode The RFG Setup menu provides a list of settings for the RF Generator. When the operator presses the RFG SETUP Soft Key Menu button, the Operator Message area displays the settings available for the RF Generator. To change a setting’s value(s): 1. Press the RFG SETUP Soft Key Menu button to display the RFG Setup settings. 2. Use the Increment/UP (▲) and Decrement/DOWN (▼) button to highlight a setting. 3. Press the SELECT Soft Key Menu button to select the highlighted setting. 4. Use the Increment/UP (▲) and Decrement/DOWN (▼) button to cycle through the values until the desired value displays. 5. Press the ACCEPT Soft Key Menu button to accept the change. 6. Press the EXIT Soft Key Menu button to return to the RF Generator screen.

Settings

Brightness The Brightness setting adjusts screen Brightness from 1 (dimmest) to 10 (brightest).

Language The Language setting selects the Language displayed on the RF Generator’s screen. The default language is English. The operator can change the default language from the RFG Setup Mode. The operator can also change the language during the Power On Self Test (POST) Mode: 1. Press the AC Power switch UP to turn on the unit. 2. When the Power On Self Test (POST) starts, simultaneously press the first two (starting at left) Soft Key Menu buttons. 3. Change the setting’s value using the Soft Key Menu buttons and the Increment/UP (▲) and Decrement/DOWN (▼) buttons.

Date The Date setting adjusts the current Date.

Time The Time setting adjusts the current Time.

Device Setup Mode

The RFG Setup menu includes these settings:

Proc Tone Vol The Proc Tone Vol setting adjusts the Procedural Tone Volume from 2 (quietest) to 10 (loudest) The Procedural Tone Volume controls the volume of alarm tones and tones associated with RF Power delivery, such as RF Power start, stop, pullback, and pullback pause tones. When the volume setting is increased or decreased, a single tone sounds to denote the change. The operator is prevented from adjusting the Procedural Tone Volume to be quieter than the Informational Tone Volume. If the operator adjusts the Procedural Tone Volume to be equal to or less than the Informational Tone Volume, the Informational Tone Volume automatically adjusts to one level lower than the Procedural Tone Volume.

Info Tone Vol The Info Tone Vol setting adjusts the Informational Tone Volume from 1 (quietest) to 9 (loudest). The Informational Tone Volume controls the volume of button acknowledgement tones and informational tones. When the volume setting is increased or decreased, a single tone sounds to denote the change.

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The Gauges setting adjusts the Parameter Range Indication gauges as either ON or OFF.

VNUS Radio Frequency Generator

The Device Setup menu provides a list of settings for the connected Device. When the operator presses the DEVICE SETUP Soft Key Menu button, the Operator Message area displays settings for the connected Device. To change a setting’s value(s): 1. Press the DEVICE SETUP Soft Key Menu button to display the Device Setup settings. 2. Use the Increment/UP (▲) and Decrement/DOWN (▼) button to highlight a setting. 3. Press the SELECT Soft Key Menu button to select the highlighted setting. 4. Use the Increment/UP (▲) and Decrement/DOWN (▼)button to cycle through the values until the desired value displays. 5. Press the ACCEPT Soft Key Menu button to accept the change. 6. Press the EXIT Soft Key Menu button to return to the RF Generator screen.

Settings Device Setup settings differ, depending on which Device the operator connects. Available settings include: • Temperature (ºC): Adjusts the desired target Temperature for Temperature Control Devices. • Maximum Power (W): Adjusts the maximum RF Power (in Watts) allowed for Temperature Control Devices. Operating Instructions

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• Power Set Point: Adjusts the desired target RF Power (in Watts) for Power Control Devices. • Maximum Voltage: Adjusts the maximum voltage (in Volts) allowed for Power Control Devices. • Treatment Time: Adjusts the maximum RF Treatment time allowed for Devices with an RF Treatment Time control. • Phase (1 or 2): Adjusts the RF Treatment time (in seconds) for ClosureFAST devices. Note that there are two phased settings to allow a higher maximum power during initial heating followed by a lower power to maintain temperature. Total treatment time is the sum of the Phase 1 and Phase 2 values, after which treatment will stop automatically.

Error Code

Description

Corrective Action

Error 23

UIC watchdog failure.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 24

Operator-stored settings invalid. Default settings restored.

The operator should review the RF Generator settings and make appropriate changes. See the “Changing Settings” section of this manual for more information.

Error 25

The inserted MultiMediaCard (MMC) does not contain valid information or is missing files.

Turn off the unit, wait a few seconds, and then turn on the unit. If the error persists, try a different MMC.

Error 26

The inserted MultiMediaCard (MMC) cannot upgrade this RF Generator because its serial number does not match.

Turn off the unit, wait a few seconds, and then turn on the unit. If the error persists, try a different MMC.

Error 27

The MultiMediaCard (MMC) software update failed.

The RF Generator needs repair. Contact the VNUS RF Generator Support Department or a local distributor.

• Unrecoverable errors halt the RF Generator and require the operator to reset the RF Generator’s AC Power to continue. If an unrecoverable error occurs, turn off the unit, wait a few seconds, and then turn on the unit. If the problem persists, contact the VNUS RF Generator Support Department or a local distributor. See Table 4 for a list of unrecoverable errors. • Recoverable errors require the operator to respond to an error message or make a clinical decision. See Table 4 for a list of recoverable errors. Table 4: Errors

Error 28

The inserted MultiMediaCard (MMC) is not correctly formatted or is an invalid type.

Data logging will be disabled. No user action required.

Error 29

The RF Generator is unable to write data to the MultiMediaCard (MMC).

Data logging will be disabled. No user action required.

Error 30

The inserted MultiMediaCard (MMC) is full and no more data can be stored on it.

Data logging will be disabled. No user action required.

Error Code

Description

Corrective Action

Error 31

The real-time clock stopped and has been restarted.

The operator should set the date and time. See the “Changing Settings” section of this manual for more information.

Error 1

Unexpected state.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 32

The inserted MMC card is not formatted.

Replace the MMC card.

Error 2

Unexpected event.

Turn off the unit, wait a few seconds, and then turn on the unit. Error 33

An Update Card was inserted after the unit was turned on.

To log data, insert a new card. To perform a software update, turn off the unit, wait a few seconds, and then turn on the unit.

Error 34

A UIC Software Task did not check in with the Task Monitor.

Turn off the unit, wait a few seconds, and then turn on the unit.

The Device determines the maximum and minimum values allowed for each setting.

Troubleshooting Error Codes If an error occurs, the RF Generator displays an error code. An error will be one of two types: unrecoverable or recoverable:

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Error 3

A parameter value was incorrect.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 4

A queue overflowed.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 5

Unit not responding.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 35

The RFG2 has experienced more than five resets in one minute.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 6

Software version incorrect.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 36

A Software Stack became corrupt.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 7

Memory corruption detected.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 37

The temperature of the RFG2 is above Allow the RFG2 to cool down before use. the specified operating temperature.

Error 8

Resource conflict.

Turn off the unit, wait a few seconds, and then turn on the unit. Error 38

The temperature of the RFG2 is below Allow the RFG2 to warm up before use. the specified operating temperature.

Error 39

Real Time Clock failure.

Error 21

RAM failure.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 22

UIC ROM failure.

Turn off the unit, wait a few seconds, and then turn on the unit.

VNUS Radio Frequency Generator

Operating Instructions

Turn off the unit, wait a few seconds, and then turn on the unit.

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Description

Corrective Action

Error Code

Description

Corrective Action

Error 40

The installed software is not compatible with the hardware revision.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 455

RFC Power Supply Temperature exceeds specification.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 41

The RFC unexpectedly reset.

Turn off the unit, wait a few seconds, and then turn on the unit. Error 457

The Device ID circuitry failed to correctly read the ID Calibration Load.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 459

The calibration coefficients are corrupt or the RFG2 has not been calibrated.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 460

RFC failed calibration check.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 461

The Primary Side Power Measurement and Device Side Power Measurement differ by more than the Turn off the unit, wait a few seconds, and then turn on the unit. allowed value.

Error 462

The Isothermal Reference and Isothermal Backup differ by more than the allowed value.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 42

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The RFC did not respond correctly to a Turn off the unit, wait a few seconds, and then turn on the unit. press of the RF Power button.

Error 43

Software corrupted

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 44

Error log was corrupt and has been cleared.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 45

Measure mode power is greater than 10mW for more than 1 second.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 46

Software unable to correctly write data to UIC Flash.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 350

The Device Temperature exceeded the Turn off the unit, wait a few seconds, and then turn on the unit. RFC Temperature Alarm Limit.

Error 468

The RFC has experienced too many resets.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 352

The Device Power exceeded the RFC Power Alarm Limit.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 469

The installed RFC software is not compatible with the hardware revision.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 354

The Device Voltage exceeded the RFC Voltage Alarm Limit.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 470

The RFC Output Relay is stuck closed.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 358

The Device was disconnected while in Turn off the unit, wait a few seconds, and then turn on the unit. Measure or RF Treatment Mode.

Error 471

The RFC Calibration Load Relay is stuck closed.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 360

The Hardware Power Limit was exceeded.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 472

The RFC Phase Offset is too large.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 363

The output relay was open when it should have been closed.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 473

The RFC Safety Enable is not functioning correctly.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 364

A broken thermocouple was detected while in Measure or RF Treatment Turn off the unit, wait a few seconds, and then turn on the unit. Mode.

Error 474

The RFC Output RF Indicator is faulty.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 450

RFC ROM failure.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 475

The RFC Adjustable Power Supply is faulty.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 451

RFC RAM failure.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 476

The RFC High Speed Analog-toDigital Converter is saturated.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 452

RFC Watchdog failure.

Turn off the unit, wait a few seconds, and then turn on the unit.

Error 477

The RFC Hardware Power Limit is faulty.

Turn off the unit, wait a few seconds, and then turn on the unit.

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Error Code

Description

Corrective Action

Difficulty

Possible Cause

Corrective Action

Error 478

The RFC Software is not able to control the isolated power supply enable.

Turn off the unit, wait a few seconds, and then turn on the unit.

Power low (Power low control Device only)

Impedance high Impedance low

Consult Device’s Instructions For Use. Consult Device’s Instructions For Use.

Error 479

The RFC Software is not able to control the RF Amplifier Enable.

Turn off the unit, wait a few seconds, and then turn on the unit.

Temperature low

Inadequate vessel exsanguination

Verify that the Device is properly positioned. Check for flow, and employ or improve compression techniques as necessary.

Error 480

RFC – 15V power supply has failed.

Turn off the unit, wait a few seconds, and then turn on the unit.

Temperature Set Point is set too low

Check and adjust Temperature Set Point.

Error 481

Frequency source of the RFC’s CPLD is not correct.

Turn off the unit, wait a few seconds, and then turn on the unit.

Saline in Device connector

Error 482

RFC has too much offset in the device ID circuit.

Check for presence of saline. If present, contact VNUS Customer Service. (Note: Take care never to plug a wet Device connector into the receptacle, as this may damage the RF Generator).

Turn off the unit, wait a few seconds, and then turn on the unit.

Device, cable, or connector is damaged

Check all connections, cable, and the Device for visible damage. Replace Device.

Temperature decreases as power is applied

Replace Device.

Saline in Device connector

Check for presence of saline. If present, contact VNUS Customer Service. (Note: Take care never to plug a wet Device connector into the receptacle, as this may damage the RF generator).

Temperature Set Point is set too high

Check Temperature Set Point.

Non-uniform temperature

Uneven compression across full length of heating element

Note Device position with shaft markers. Check Device and replace if damaged. If not damaged, insert Device to desired location, Verify that the Device is properly positioned. Employ or improve compression techniques as necessary. Press the START RF button or the Device handle button to activate RF Power.

Impedance low (not displayed)

Saline in Device connector and/ or receptacle

Check for presence of saline. If present, contact VNUS Customer Service. (Note: Take care never to plug a wet Device connector into the receptacle, as this may damage the RF Generator.) If saline is not present in Device connector or receptacle, perform a Saline Test to verify functionality of Device. Replace Device or instrument cable if Saline Test Impedance values are out of range.

Short circuit

Replace Device.

Open circuit

Check Device connection (disconnect and then reconnect).

RF Treatment Difficulties During RF Treatment, the RF Generator monitors the Device’s parameters (Temperature, Impedance, and RF Power). Should Temperature, Impedance, or RF Power become too high or too low, as indicated by its gauge, the RF Generator may halt RF Treatment, sound an alarm, and display an alarm message (Impedance is not displayed for ClosureFAST).

Temperature high

Tables 5 and 6 provide general recommendations for some situations that the operator might encounter. They do not include every possible situation that might occur. For more information, please refer to the Device’s Instructions for Use and/or clinical training materials provided by VNUS. Table 5: RF Treatment Difficulties – ClosureFAST Difficulty

Possible Cause

Corrective Action

Unable to activate RF Power

Temperature and/or Impedance parameter outside Functional Limits

Check Temperature value; adjust as necessary to bring parameters into Functional range.

Ready Mode not entered

Press the non-illuminated RF Power button and observe that it flashes on and off to indicate the RF generator is in ready Mode. Then, activate RF Power when ready.

Body temperature not measured

Verify that the Device has been inserted into the body and is properly positioned to begin treatment. Press (OK to proceed) and then press the START RF button or the Device handle button to activate RF Power.

Power high

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Connected device is broken

Check the Device connector to verify that it is plugged in properly. Replace Device.

Inadequate vessel exsanguination

Verify that the Device is properly positioned. Check for flow, and employ or improve compression techniques as necessary.

VNUS Radio Frequency Generator

Impedance high (not displayed)

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Table 6: RF Treatment Difficulties - ClosurePlus, ClosureRFS, and ClosurePlex Difficulty

Possible Cause

Corrective Action

Impedance low

Inadequate electrode-vein wall contact

Improve or employ vein compression techniques.

Saline in Device connector and/ or receptacle

Check for presence of saline. If present, contact VNUS Customer Service. (Note: Take care never to plug a wet Device connector into the receptacle, as this may damage the RF Generator.) If saline is not present in Device connector or receptacle, perform a Saline Test to verify functionality of Device. Replace Device or instrument cable if Saline Test Impedance values are out of range.

Impedance high

Power low (Power Control Devices only)

Power high

Temperature low

Possible Cause

Corrective Action

Temperature high

Saline in Device connector

Check for presence of saline. If present, contact VNUS Customer Service. (Note: Take care never to plug a wet Device connector into the receptacle, as this may damage the RF generator.) If saline is not present in Device connector or receptacle, perform a Saline Test to verify functionality of Device. Replace Device or instrument cable if Saline Test Impedance values are out of range.

Temperature Set Point is set too high

Check Temperature Set Point.

Temperature and/or Impedance parameter outside Functional Limits

Check Temperature and Impedance parameter values; adjust as necessary to bring parameters into Functional range.

Unable to activate RF Power

Short circuit

Replace Device.

Device electrodes not open or exposed

Check Device to ensure electrodes are properly exposed.

Coagulum formation on electrodes

Check Device tip for coagulum and remove as required. Verify Device saline drip rate.

Device not in contact with target tissue

Verify that Device is properly positioned.

Open circuit

Check Device connection (disconnect and then re-connect).

Pullback rate too slow

Verify pullback rate. Consult Device’s Instructions for Use.

Impedance high

Consult Device’s Instructions for Use.

Impedance low

Consult Device’s Instructions for Use.

Too much blood flow Pullback rate too fast

Check and improve exsanguination. Verify proper pullback rate.

Saline drip too high

Check and adjust saline drip rate.

Electromagnetic Interference (EMI)

Saline drip too cold

Check and adjust saline temperature.

Inadequate vessel exsanguination

Verify that the Device is properly positioned. Check for flow, and employ or improve compression techniques as necessary.

The RF Generator might cause interference that can affect other equipment. Such interference might occur during RF Treatment Mode or during any mode that performs low power measurements, such as Measure, Body Test, or Saline Test Modes.

Pullback rate too fast

Verify proper pullback rate.

Temperature Set Point is set too low

Check and adjust Temperature Set Point.

Saline in Device connector

Check for presence of saline. If present, contact VNUS Customer Service. (Note: Take care never to plug a wet Device connector into the receptacle, as this may damage the RF Generator.) If saline is not present in Device connector or receptacle, perform a Saline Test to verify functionality of Device. Replace Device or instrument cable if Saline Test Impedance values are out of range.

Device, cable, or connector is damaged

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Difficulty

Check all connections, cable, and the Device for visible damage. Replace Device.

VNUS Radio Frequency Generator

If interference affects other equipment in the treatment area, move the RF Generator to a different location and move the RF Generator cord and the Device away from the susceptible equipment and its cords and cables. The RF Generator is susceptible to interference from EMI emitted by other equipment. This could result in inaccurate RF Power delivery and possible injury to the patient. Additionally, RF Treatment might halt or the unit might restart due to a non-repeating event, such as memory corruption related to electrical or radiation events, power surges, or power spikes. Possible sources of EMI interference can include, but are not limited to, cellular phones, radio transmitters, motors, telephones, lamps and other medical equipment, such as electrosurgical products and defibrillators. Restrict the use of this equipment in the vicinity of the RF Generator.

Technical Assistance To obtain technical assistance, call the VNUS Technical Support Department or a local distributor. See the front of this manual for contact information. Operating Instructions

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Service and Maintenance

5 x20 mm fuses

AC Power switch

Cleaning and Disinfection Caution: Always unplug the AC Power cord prior to cleaning the RF Generator. Avoid spilling liquids into the RF Generator during cleaning. Avoid getting cleaning materials inside Device receptacle.

The RF Generator requires no scheduled maintenance other than cleaning external surfaces. It is recommended that the operator clean the unit prior to each use or as needed. Fuse holder

The recommended agents for cleaning RF Generator surfaces (not including the LCD screen) to prevent surface degrading or discoloration include the following: • Five percent solution of household bleach (approximately 2,500 ppm Sodium Hypochlorite) • Sporicidin® • IPA 70/30

Latch AC Power inlet

The recommended agent for cleaning the transparent, protective cover of the LCD screen is IPA 70/30. RF Generator cannot be sterilized and must not enter a sterile surgical field.

Figure 15: Fuse Replacement

9.2 Fuse Replacement The RF Generator uses two 4A/250V, slo-blo, 5x20 mm fuses. In the event of a fuse failure, replace the fuses using the following procedure, as shown in Figure 15:

Caution: Fuses must be replaced with 4A/250V, slo-blo, 5x20 mm fuses. Using other fuses might damage the unit.

1. Disconnect the RF Generator’s AC Power cord from the AC Power outlet. 2. Remove the slide-in fuse holder by inserting a small blade screwdriver into the slot located on the bottom side of the holder while activating the latch, and then pull out the holder by hand until the holder slides out. 3. Remove the holder completely by hand and replace the fuse(s). 4. Reinsert the fuse holder by pushing it with the thumb until the holder’s front surface is flush with the power entry module’s surface and the latch engages.

Warranty For information about the RF Generator warranty and/or to obtain information about the availability of the VNUS Extended Warranty, contact VNUS Customer Service. See the front of this manual for contact information. Opening the RF Generator by anyone other than an authorized VNUS technician voids the warranty.

Repairs and Returns The RF Generator contains no operator-serviceable parts. The RF Generator must be either returned to the factory or repaired by qualified service personnel. For RF Generator repairs or returns, call the VNUS Customer Service Department. See the front of this manual for contact information. A Customer Service Representative will assist the operator with obtaining service or returning the RF Generator, as appropriate. The RF Generator must be unplugged before servicing.

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VNUS Radio Frequency Generator

WARNING: Do not remove the cover of the RF Generator, as there is a potential for electrical shock.

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Disposal

Accuracy

Follow local governing ordinances and recycling plans regarding disposal or recycling of components.

Accuracy measurements for the RF Generator include:

WARNING: The RF Generator includes a lithium battery. Do not incinerate or dispose of lithium batteries in general trash collection. Check state and local regulations dealing with the disposal of these materials

Technical Specifications

• Temperature Measurement: The Device thermocouple is measured with an accuracy of ±2°C over the Temperature range of 20°C to 125°C. • Impedance Measurement: The Impedance is measured with an accuracy of ±5% of the measured value, or ±5Ω, whichever is greater. • RF Power Measurement: RF Power is measured on the isolated patient circuit and is the average Real Power, with an accuracy of ±5% of the measured value, or ±0.05W, whichever is greater.

Electrical

Equipment Type

The RF Generator:

The RF Generator meets the specifications for Class 1, Type CF, Defibrillator-Proof Applied Part.

Environmental Conditions Transportation and Storage During transportation and storage, adhere to these guidelines: • Store the RF Generator at temperatures between –20°C and 60°C and in non-condensing relative humidity between 0% and 90%. • Do not stack items on top of the RF Generator. • When the RF Generator is not in use, unplug the unit from the AC Power outlet and wrap the cord around the AC Power cord wrap area. • Do not carry or lift the RF Generator by the AC Power 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. • Allow at least 15 minutes after removing the RF Generator from a storage environment before turning on the unit. This lets the unit fully acclimate to the environment. Operation Conditions for operating the RF Generator include the following: • Temperature between 10ºC and 40ºC. Relative humidity (non-condensing) between 0% and 90%

RF Power Delivery Performance

• Operates from an AC Power source ranging from 100 to 240V RMS, 50 to 60Hz. • Includes a DIN 42801–compatible equipotential grounding lug that meets the ground bond requirements of UL 2601–1. • Is equipped with a hospital-grade detachable AC Power cord, at least 3.048 m (10 ft.) in length, constructed of UL-rated cord type of SJO, SJT, or SJE per UL 2601–1 Section 57.3.

Impedance and Power The Generator has the RF Power capacity to deliver RF Power into loads of various Impedances, as shown in Figure 16, where: • Region A Power Capacity ≥ (1.25*Real Impedance)W when 5.0Ω ≤ Real Impedance < 20.0Ω • Region B Power Capacity ≥ 25.0W when 20.0Ω ≤ Real Impedance ≤ 500Ω • Region C Power Capacity ≥ (12500/Real Impedance)W when 500Ω < Real Impedance ≤ 1999Ω • Region CLF Power Capacity ≥ 40.0W when 100Ω ≤ Real Impedance ≤ 250Ω The RF Power capacity is also limited by the Maximum Power (W) setting of the connected Delivery Device. Please read the Delivery Device’s Instructions for Use for more information

Mechanical Specifications • Size: 38 cm x 38 cm x 19 cm (15 in. x 15 in. x 7.5 in.) maximum • Weight: 8 kg (18 lbs.) maximum

Compliance The RF Generator meets the compliance requirements of the following standards:

The fundamental frequency of the RF signal is set at 460kHz. Output frequency does not vary more than ±250Hz under all specified operating and loading conditions.

• IEC 60601–1

• IEC 60601–1–8

The Power Control Mode is designed to have a steady-state power error of less than ± 2% or ±0.05W, whichever is greater, of the Power Set Point over an Impedance range of 20Ω to 500Ω.

• IEC 60601–1–1

• UL 2601–1

Temperature Control Mode has a steady-state error of less than ± 2°C of the Temperature Set Point unless RF Power or Impedance limits are exceeded. The Temperature Set Point is adjustable from 50°C to 120°C with a resolution of 1.0°C. Specific RF Treatment parameter limits can reduce this range.

• IEC 60601–1–2

• IEC 60601–2–2

• IEC 60601–1–4

• ANSI/AAMI HF18

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VNUS Radio Frequency Generator

Operating Instructions

34

Français

Français

Region B

Region A

Region C

Region CLF

25

40

Power (W)

Real Power (W)

25

10

Power Delivery Capacity

6.25

5

0

0

0 5

20

100

250

500

Power Delivery Capacity

0

1999

20

500

Impedance (Ω)

Real Impedance (Ω)

Figure 18: Impedance v. RF Power Curve (ClosurePlus)

Figure 16: Real Impedance v. RF Power Curve

25 20 Power Delivery Capacity

Power (W)

Power (W)

40

20

Power Delivery Capacity

10

0 0

0 0

100

Impedance (Ω)

250

VNUS Radio Frequency Generator

245

500

Impedance (Ω)

Figure 19: Impedance v. RF Power Curve (RFS)

Figure 17: Impedance v. RF Power Curve (ClosureFAST)

35

20

Operating Instructions

36