Covidien VNUS RFG2 Bedienungsanleitung

VNUS™

Radio Frequency Generator

RFG

PLUS

Model RFG2 Operator’s Manual

Table of Contents

Introduction ............................................................... 1

Intended Use ...................................................................1

General Safety Guidelines ........................................................1

Precautions/Operation Warnings and Cautions.......................................2

RF Treatment Warnings and Cautions ...............................................2

Environmental Conditions ........................................................3

Unpacking and Inspection of Components ..........................................3

Setup and Installation............................................................4

Mechanical Specications ........................................................4

Equipment Type.................................................................4

Equipment Description ...................................................... 5

Labeling Symbols ...............................................................5

Visual Indicators ................................................................6

Audible Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

Front Panel .....................................................................7

Rear Panel .....................................................................8

LCD Screen – ClosureFAST .........................................................9

LCD Screen – ClosureRFS.........................................................10

Gauges – ClosureFAST ..........................................................11

Gauges – ClosureRFS............................................................12

Instructions for Use ........................................................ 13

AC Power......................................................................13

Changing Settings..............................................................13

Connecting a Device ............................................................14

Measure Mode .................................................................15

RF Treatment - ClosureFAST ......................................................16

RF Treatment - ClosureRFS .......................................................18

Using MultiMediaCards (MMCs) ..................................................19

Functional and Advisory Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

Operating Modes .......................................................... 21

Power On Self Test (POST) Mode ..................................................21

Identication Mode.............................................................21

Measure Mode .................................................................22

Saline Test Mode - ClosureRFS only ................................................22

Body Test Mode - ClosureRFS only.................................................23

Alarm Acknowledge Mode.......................................................23

Ready Mode - ClosureFAST only...................................................23

RF Treatment Mode .............................................................23

Error Mode ....................................................................24

RFG Setup Mode ...............................................................24

Device Setup Mode .............................................................25

Maintenance.............................................................. 26

Cleaning and Disinfection .......................................................26

Disposal ......................................................................26

Troubleshooting........................................................... 27

Technical Assistance ............................................................27

Error Codes ....................................................................27

RF Treatment Diculties.........................................................27

Electromagnetic Interference (EMI) ...............................................30

Glossary of Terms .......................................................... 31

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Operator’s Manual

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VNUS Radio Frequency Generator

Introduction

Prior to using the RF Generator, review the warnings and cautions in this manual for important safety

information.

The VNUS Radiofrequency Generator (RFG

PLUS

) 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.

Please refer to the Instructions for Use included with the RF Device for information related to the Device such

as clinical procedures, cautions, warnings, precautions, potential complications, and contraindications.

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.

Caution: US federal law restricts this device to sale by or on the order of a physician.

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ACPowercordisdamaged.

 • Inspectallcordsandcablesregularlyforwearordamage.Discontinueuseanddiscardifdamaged.

 • Donotuse3–to–2pronggroundingadapters.

 • AlwaysuseanACPowercenter-tapconfigurationfor240V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Generator’s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isapotentialforelectricalshock.

 • Alwaysrefertoauthorizedpersonnelforservice.

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

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aflammableanestheticmixturewithair

orwithoxygenornitrousoxide.

 • UsetheVNUSRFGeneratoronlywithVNUSClosureFAST 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patient,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RFPoweruntiltheDeviceisproperlypositionedinthepatient.

 • RFPoweractivationtonesandlightsareimportantsafetyfeatures.Donotobstructlights.Donot

disable auditory tones.

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VNUS Radio Frequency Generator

Environmental Conditions

Transportation and Storage

During transportation and storage, adhere to these guidelines:

 • StoretheRFGeneratorat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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.

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ACPower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ACsources.

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:38cmx38cmx19cm(15in.x15in.x7.5in.)maximum

 • Weight:9kg(20lbs.)maximum

Equipment Type

The Class I RF Generator is designed to work with Type CF, Defibrillator-Proof RF Devices.

TheRFGeneratorisdesignedtowithstandanapplicationofanexternaldefibrillatorwhile

the RF Device is in use.

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VNUS Radio Frequency Generator

Equipment Description

Labeling Symbols

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

ΩOhms (Impedance) Information, Question, or

Verication

°C Degrees Celsius

(Temperature)

Warning: Consult

alarm/advisory message

WWatts (Power) Data Logging Indicator

ClosureFAST icon:

RF not actively

powered OR

ClosureFAST icon:

RF actively powered to cause

tissue heating

Table 2: RF Generator Symbols and Icons

AC Power ON Non-IonizingRadiation

AC Power OFF

Earth Ground

RF Power ON MMC Card MultiMediaCard (MMC) Slot

RF Power OFF Increment/UP

Attention: Consult

accompanying documents Decrement/DOWN

Fuses Patient Isolated

Alternating Current Electrostatic Sensitive Device

(referring to MMC card)

Visual Indicators

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. Identication 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

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

Audible Indicators

The RF Generator has several audible indicators designed to alert the operator:

• Alarm: Set of three rapid, high-frequency tones. Sound pressure level of alarm tones is

> 45dB (procedural tone volume at quietest setting) and

> 80dB (procedural tone volume at loudest setting).

 • 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

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.

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VNUS Radio Frequency Generator

Front Panel

LCD Screen

RF Power

Button and

Indicator

Delivery

Device

Receptacle

Increment/UP and

Decrement/DOWN Buttons

Soft Key Menu

Buttons

AC Power

Indicator

Vent Slots

Figure 1: Front Panel

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(p) and Decrement/DOWN (q): 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.

Rear Panel

AC Power Cord Wrap

AC Power Inlet

Equipotential

Grounding Lug

Fuse Holder

MMC

Slot

Handle

Vent

Openings

Service

Port

AC Power Switch

Figure 2: Rear Panel

The RF Generator includes these features, as depicted in Figure 2:

 • 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) Slot: Accepts a MultiMediaCard that can be used to store procedure data

and to perform software upgrades.

 • Service Port: The RF Generator includes a 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.

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LCD Screen – ClosureFAST

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

Device

Temperature

Data Logging

Indicator Timer Device ID

Operator

Message

Area

Data Display

Area

Soft Key

Area

Progress Meter RF Power

Gauges

Figure 3: ClosureFAST Main Screen

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 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.

 • Progress Meter: Indicates treatment time remaining

 • Timer: The timer counts down starting from the selected treatment time.

•RF Power: Indicates current RF Power delivered to the Device.

LCD Screen – ClosureRFS

Device

Temperature

Set Point

Data Logging

indicator Timer Device ID

Operator

Message

Area

Data Display

Area

Soft Key

Area

Device

Impedance

RF Power

Gauges

Figure 4: ClosureRFS Main Screen

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 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 whetherTemperature, Impedance, and RF Power are within or outside of preset limits.

 • 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.

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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.

Gauge within

normal range

Upper Advisory

Limit violated

Power Gauge with reference

ticks at 10, 20, 30 and 40 Watts

Operator

Message

Area

Lower

Advisory

Limit

violated

Figure 5: 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: Power above Advisory Limit

For more information about these Limits, see the “Functional and Advisory Limits” section of this manual.

Gauges – ClosureRFS

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.

Gauge within

normal range

Upper Advisory

Limit violated

Gauge within

normal range

Operator

Message

Figure 6: ClosureRFS 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)

Yellow

(upper)

Red

(upper)

Yellow

(lower) Green

Gauge

needle

Figure 7: Gauge

For more information about these Limits, see the “Functional and Advisory 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.

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.

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.

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.

  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).

 • SELECT: Indicates the options for the highlighted setting.

 • EXIT: Returns to the previous screen.

2. Use the Increment/UP (p) and Decrement/DOWN (q) 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 (p) and Decrement/DOWN (q) 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 unit is

turned on before a Device is attached, the RF Generator prompts the operator to connect a Device.

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.

Device

connector

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.

Français

Operator’s Manual

Français

VNUS Radio Frequency Generator

Measure Mode

RF Power

Device

Temperature

Data Logging

Indicator Timer Device ID

Soft Key

Menu Area

Figure 9: ClosureFAST Measure Mode

RF Power

Device

Temperature

Device

Impedance

Data Logging

Indicator Timer Device ID

Soft Key

Menu Area

Figure 10: ClosureRFS Measure Mode

RF Treatment - ClosureFAST

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.

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.

Data Logging

Indicator Countdown Timer Device ID

Soft Key

Gauges

during

Treatment

Mode

Operator

Message

Area

Figure 11: ClosureFAST RF Treatment Started

Andere Handbücher für VNUS RFG2

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