Covidien VNUS RFG2 User manual

VNUS™
Radio Frequency Generator
RFG PLUS Model RFG2 Service Manual

1
Service Manual
en
Table of Contents
Description ................................................................ 1
Front and Rear Panel Layout ......................................................1
System Overview................................................................2
UI Board .......................................................................2
Front Panel Interface Assembly (FPI) ...............................................3
RF Board .......................................................................3
MMC/USB Assembly .............................................................3
AC Power Board .................................................................3
Isolation Barrier.................................................................3
Operating Assumptions forVNUS RFG2 RF Generator..................................5
Basic Inspection and Checkout Procedure ...................................... 5
Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Functional Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
Power On Self Test...............................................................5
SoftwareVersion ................................................................6
Electrical Safety Tests ....................................................... 6
Electrical SafetyTests 220-240V ...................................................6
Electrical SafetyTests 110-120V ...................................................7
Electromagnetic Compliance ......................................................8
Biomedical Department Power Output Test.................................... 12
Power Delivery Verication ................................................. 13
Alarm Priority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Error Codes ............................................................... 14
Service and Maintenance ................................................... 16
Cleaning and Disinfection .......................................................16
Repairs and Returns ............................................................16
Warranty......................................................................16
Fuse Replacement ..............................................................17
Technical Specications .................................................... 18
EquipmentType................................................................18
Electrical......................................................................18
RF Power Delivery Performance ..................................................18
Tolerances.....................................................................18
Description
Front and Rear Panel Layout
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
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

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System Overview
The VNUS RFG2 RF Generator supplies and controls the RF energy delivered to the RF Device. 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.
The RF Generator consists of five main sections: UI Board, Front Panel Interface Assembly (FPI), RF Board,
MMC/USB Assembly, and AC Power Board. A commercially available, medical grade, switching power
supply is used to provide low-voltage power to supply the Generator’s internal circuitry.
The major functional blocks of the VNUS RF Generator electronics are presented below in Figure 3.
AC Power
Switch
Memory Card
Port
AC Inlet USB Port
Fan MCI
AC Power Board ECI
AC Inlet ECI
Speaker
ECI
Switch
Press
Signal
Power
Indicator
Control
Display
Control
Interface
Power
On LED
Signal
Display
Backlight
Power
Keypad
Backlight
Power
Keypad
Press
Power
Device
Connector
Signals
RF Switch ECI Front Panel Electronics ECI
Device Connector
RF Output Connector
ECI
RF Power
Switch
RF Power
Indicator
Display
Keypad
Power On
LED
Display
Analog
Audio
120-
240VAC
USB/MMC
Signals 24VDC
Fan Power
Speaker
RCIP RF Board ECI
Enclosure MCI
UI Control Board ECI
Figure 3: Block Diagram of the VNUS RFG2 Radiofrequency Generator
UI Board
All User Interface controls and indicators are managed and/or generated by the UI control circuitry. The
UI Board is the large (app. 20”x5”) PCB mounted vertically inside the chassis directly behind the LCD
display. It controls all electronics that handle basic system operation and User Interface control. It also
contains the RF Switch Circuitry for turning off/on RF power. In addition, the LCD Backlight Inverter
(small 1”x4” PCB) is mounted to the UI Board. It is controlled by the UI Board and used for powering the
6.4” LCD display CCFL backlight tubes.
Front Panel Interface Assembly (FPI)
The Front Panel Interface Circuitry consists of 2 circuit boards (the UI Horizontal and UI Vertical keypad
boards), and the RF switch circuitry, which is included on the UI board. The UI Horizontal and UI Vertical
PCBs (also referred to as the keypad boards) contain the 6 general purpose keys and backlighting below
(UI Horizontal Board) and to the right (UI Vertical Board) of the LCD display (as viewed from the front of
the Generator). The RF Switch circuitry (contained on the UI Board) provides the switch and colored-
backlighting for the RF on/off switch located on the right of the FPI (as viewed from the front of the
Generator).
RF Board
The RF Generation Board generates a RF sinewave at 460.8 kHz, and provides the UI Board with
measurements of delivered voltage, current and power. The RF Board controls the RF output by enabling
RF generation and by controlling the amount of voltage delivered by the RF Board. The RF Board is the
large (app. 8”x6”) PCB mounted horizontally in the bottom of the chassis on the right side (as viewed
from the front of the Generator). The RF Board controls all electronics that generate the RF power used
to drive the device. Additional safety signals and control are provided by the UI Board through the 16
position IDC cable that runs between the UI and RF board.
MMC/USB Assembly
The MMC/USB Assembly is incorporated on the AC power board and refers to all MMC/USB related
components. These components primarily consist of an MMC slot, a USB host controller, and filter
components out on the AC Power Board. The UI processor (on the UI Board) controls the MMC and USB.
The UI processor is connected to the components on the AC Power Board via the 14 position IDC cable in
the left front corner (as viewed from the front of the Generator).
AC Power Board
The AC Power Board is the large (app. 8”x6”) PCB mounted horizontally in the bottom of the chassis on
the left side (as viewed from the front of the Generator). The AC Power Board controls the AC/DC power
supply (and related circuitry) that generate 24 Volts to drive the system. The AC Power Board also
monitors over-temperature conditions and drives the fan circuitry. The MMC/USB card slot, connector,
and filter circuitry are also contained on this PCB.
Isolation Barrier
For the patient safety, an electrical isolation barrier is designed into the RF Board. The Isolation Barrier
separates the Patient Connected side and the Non-Patient Connected side. There is 4000 VDC separation
between AC Mains, Functional Grounds, Earth Ground and all exposed surfaces from patient contact. All
devices (relay, transformer and opto-isolators) also have a minimum of 4000 VDC isolation between
inputs and outputs.
The instantaneous voltage and instantaneous current of RF Output are fed back across the isolation
barrier and input directly to an ADC.
Two power supplies, a +5V and a +2.5V supply are on the patient side of the isolation barrier. The
capacity of the +5V supply is 50mA.
The isolated 5V supply is the source for the +2.5V supply. The output capacity of 25mA. It is used in the
Patient Connected Circuitry.

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Patient
Connections
Plastic
Metal
Figure 4: VNUS Radiofrequency Generator Grounding and Isolation Diagram
Table 1: Compliance Requirements for Isolation Barriers in Figure 4
Isolation Type Air Clearance
(mm)
Creepage
(mm)
Test
Voltage
ABOP (240VAC) 1.6 3 1500
BBI (240VAC) 2.5 4 1500
CDI (240VAC) 5 8 4000
DBI (240VAC) 2.5 4 1500
EDI/RI (240VAC) 5 8 4000
FDI/RI (130VAC), BI (240VAC) 5 8 4000
GDI/RI (130VAC), BI (240VAC) 5 8 4000
HDI/RI (130VAC), BI (240VAC) 5 8 4000
I17.g.5 Protective Impedance, Max EARTH leakage = 0.5mA
JDI/RI (1000VAC) 18 32 7000
KDI/RI (240VAC) 5 8 4000
LBI (240VAC) 1.6 3 1500
MFunctional Only na na na
NFunctional Only na na na
PDI/RI (240VAC) 5 8 4000
Abbreviations in Table 1
Air Clearance - Shortest path in air between two conductive parts
BOP - Basic insulation between Parts of Opposite Polarity.
BI - Basic Insulation
Creepage - Shortest path along the surface of insulating material between two conductive parts
DI - Double Insulation
Functional Only - Insulation that does not perform a safety function
RI - Reinforced Insulation
Operating Assumptions for VNUS RFG2 RF Generator
 • The RF Generator should be used only with a Hospital Grade power cord and plugged into only
grounded, Hospital Grade AC sources.
 • ClassI,TypeCF,Defibrillator-ProofAppliedPart.
 • PlasticandMetalEnclosure.
 • ServicePortisnotuser-accessible(factoryuseonly).ServicePortiscoveredbyaplasticcoverthat
can only be removed with a tool.
 • ServicePortisUL1950,50VDCNormal/MAINSVinSingleFaultCondition.
 • MetalEnclosureisProtectiveEarth.
 • Displayhasnotouchscreen,andsitsbehindprotectiveplasticcover.
 • PatientConnectionisBipolarCatheter.
 • ThedisplaybacklightoperatesoffaDCtoACinverter.Theinputis5VDCandtheoutputproduces
335 VRMS. The starting voltage is 1200 VRMS and lasts for milliseconds until the bulb lights.
 • IsolatedPatientConnectionsincludeDevice,Thermocouple,andIDResistor.
 • MMCisplasticofunknowninsulationpropertiesandisoperator-accessiblewhendeviceispowered.
 • MMCpinsarenotuser-accessible.
Basic Inspection and Checkout Procedure
Visual Inspection
 • Inspectallexternalreceptacleconnectorsforbentpins,foreignobjects,damagedcaseand/or
improper fit.
 • InspecttheACpowercordforobviousphysicaldefectsordamage.
Functional Inspection
The VNUS RF Generator, RFG2 is designed to operate over line voltage range of 100-240 VAC, 50-60Hz,
therefore no changes to the RFG2 are required when changing the mains voltage over this range. An
appropriate power cord compatible with the outlet type in your area is required.
Plug power cord into power outlet, turn on main power to Generator. (Switch is located on the rear of
unit).
Power On Self Test
Proper execution of the Power On Self Test internally verifies that the VNUS RF Generator is ready for
operation.
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 Customer Service.

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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.
Software Version
The RF Generator’s software release version will be displayed when the Power On Self Test is completed.
The RFG2 enters Identification Mode as shown in Figure 5 below.
RFG2 - VERSION 4.1.0
Figure 5: Identification Mode Showing Software Version
Electrical Safety Tests
The VNUS RF Generator has been thoroughly tested for isolation, leakage, and grounding integrity prior
to shipment. Should it become necessary to perform these tests, the use of the appropriate test
equipment,andknowledgeoftheappropriatesectionsofBSEN60601-1:1990+A1+A2whichpertain
to these tests is mandatory. VNUS Medical Technologies assumes no responsibility for damage to the
instrument due to improper application of the tests below. If in doubt, consult the Safety Analyzer Users
Manual or VNUS Medical Technologies prior to conducting the following tests.
Electrical Safety Tests 220-240V
A special test cable from VNUS is available for these tests. Please contact VNUS Customer Service for
information on obtaining the Biomed Test Cable (TL100-119-02).
1. Set the line voltage to 264V and set the frequency to 50Hz. DO NOT EXCEED 280V!
2. Plug the line cord of theVNUS Generator into the leakage tester for all tests.
3. For source leakage and isolation tests, use the Biomed Test Cable to access patient connections. Short
electrodes and thermocouple wires together for testing.
4. For the 25A test, connect the ROD-L leads to the chassis ground lug, and to the ground pin of the
power cord.
WARNING! HIGH VOLTAGE! DO NOT TOUCH THE EQUIPMENT DURING THE ISOLATION TESTS!
Table 2: Electrical Safety Test Limits 240V
Parameter Conditions Passing
InputVoltage Rated line + 10% 264V
Line Cord Resistance N/A < 100mΩ
25A chassis-cord gnd 10 seconds < 100mΩ
Earth Leakage Power Norm, GND OPEN < 500 μA
Earth Leakage Power Rev, GND OPEN < 500 μA
Source Leakage, Applied Part Power Normal, GND OPEN < 10 μA
Source Leakage, Applied Part Power Reversed, GND OPEN < 10 μA
IsoTest, Applied Part Power Normal < 10 μA
IsoTest, Applied Part Power Reversed < 10 μA
Electrical Safety Tests 110-120V
1. Use the variable autotransformer and the DVM to set the line voltage to 132V. DO NOT EXCEED 140V!
2. Plug the line cord of theVNUS Generator into the leakage tester for all tests.
3. For source leakage and isolation tests, use the Biomed Test Cable to access patient connections. Short
electrodes and thermocouple wires together for testing.
4. For the 25A test, connect the ROD-L leads to the chassis ground lug, and to the ground pin of the
power cord.
WARNING! HIGH VOLTAGE! DO NOT TOUCH THE EQUIPMENT DURING THE ISOLATION TESTS!
Table 3: Electrical Safety Test Limits 120V
Parameter Conditions Passing
InputVoltage Rated line + 10% 132V
Line Cord Resistance N/A < 100mΩ
25A chassis-cord gnd 10 seconds < 100mΩ
Earth Leakage Power Norm, GND OPEN < 300 μA
Earth Leakage Power Rev, GND OPEN < 300 μA
Source Leakage, Applied Part Power Normal, GND OPEN < 10 μA
Source Leakage, Applied Part Power Reverse, GND OPEN < 10 μA
IsoTest , Applied Part Power Normal < 10 μA
IsoTest, Applied Part Power Reversed < 10 μA

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Electromagnetic Compliance
Standards referenced in tables 4 and 5:
CISPR11:2009(AmendedbyA1:2010),Industrial,scientificandmedical(ISM)radio-frequency
equipment - Electromagnetic disturbance characteristics - Limits and methods of measurement
IEC61000-3-2:2009,Electromagneticcompatibility(EMC)-Part3-2:Limits-Limitsforharmonic
current emissions (equipment input current ≤ 16 A per phase)
IEC 61000-3-3:2008, Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage
fluctuations and flicker in low-voltage supply systems for equipment with rated current ≤ 16 A
IEC 61000-4-2:2008, Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement
techniques - Electrostatic discharge immunity test
IEC 61000-4-3:2008, Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement
techniques - Radiated, radio-frequency, electromagnetic field immunity test
IEC 61000-4-4:2004, Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement
techniques - Electrical fast transient/burst immunity test
IEC 61000-4-5:2005, Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement
techniques - Surge immunity test
IEC 61000-4-6:2008, Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement
techniques - Immunity to conducted disturbances, induced by radio-frequency fields.
IEC61000-4-8:2009,Electromagneticcompatibility(EMC)-Part4-8:Testingandmeasurement
techniques - Power frequency magnetic field immunity test
IEC 61000-4-11:2004, Electromagnetic compatibility (EMC) - Part 4-11: Testing and measuring
techniques - Voltage dips, short interruptions and voltage variations immunity tests
Table 4: Electromagnetic Emissions
Guidance and manufacturer’s declaration - electromagnetic emissions
The RF Generator is intended for use in the electromagnetic environment specied below. The
customer or the user of the RF Generator should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 2 The RFG2 must emit electro-magnetic energy in order
to perform its intended function. Nearby electronic
equipment may be aected.
RF emissions
CISPR 11
Class A The RFG2 is suitable for use in all establishments
other than domestic and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage uctuations/ icker
emissions IEC 61000-3-3
Complies
Table 5: Electromagnetic Immunity
Guidance and manufacturer’s declaration - electromagnetic immunity
The RF Generator is intended for use in the electromagnetic environment specied below.
The customer or the user of the RF Generator should assure that it is used in such an environment.
IMMUNITY test IEC 60601
test level
Compliance level Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors shall be wood, concrete or
ceramic tile. If oors are covered
with synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient/ burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 2 kV for power
supply lines
Not applicable
Mains power quality should be that
of a typical commercial or hospital
environment. If disruption in power
occurs, it may be necessary to reset
the unit by disconnecting and
reconnecting the catheter.
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage
dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % UT
(>95%dipinUT)
for 0.5 cycle
40 % UT
(60% dip in UT)
for 5 cycles
70 % UT
(30% dip in UT)
for 25 cycles
<5 % UT
(>95%dipinUT)
for 5 s
<5 % UT
(>95%dipinUT)
for 0.5 cycle
40 % UT
(60% dip in UT)
for 5 cycles
70 % UT
(30% dip in UT)
for 25 cycles
<5 % UT
(>95%dipinUT)
for 5 s
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
RFG2 requires continued operation
during power interruptions, it is
recommended that the RFG2 be
powered from an uninterruptible
power supply or a battery.
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic elds
should be a levels characteristic
of a typical location in a typical
commercial or hospital environment.

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10 VNUS Radio Frequency Generator
Guidance and manufacturer’s declaration - electromagnetic immunity
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3Vrms
150 kHz to 80 MHz
3V/m
80 MHz to 2.5 GHz
3Vrms
3 V/m
Portable and mobile RF
communications equipment should
be used no closer to any part of the
RFG2, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
d=1.2 √P
d=1.2 √P 80 MHz to 800 MHz
d=2.3 √P 800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in metres (m).
Field strengths from xed RF transmitters,
as determined by an electromagnetic
site survey,ashould be less than the
compliance level in each frequency
range. b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE UTis the a.c. mains voltage prior to application of the test level.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and
reection from structures, objects and people.
a) Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast andTV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey
should be considered. If the measured eld strength in the location in which the RF Generator is used exceeds
the applicable RF compliance level above, the RF Generator should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the RF
Generator.
b) Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3V/m.
Table 6: Separation Distances
Recommended separation distances between portable and mobile
RF communications equipment and the RF Generator
The RF Generator is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the RF Generator can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the RF Generator as recommended below, according
to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d=1.2 SP
80 MHz to 800 MHz
d=1.2 SP
800 MHz to 2.5 GHz
d=2.3 SP
0.01 0.1 0.1 0.2
.1 0.4 0.4 0.7
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2These guidelines may not apply in all situations. Electromagnetic propagation is aected by
absorption and reection from structures, objects and people.

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12 VNUS Radio Frequency Generator
Biomedical Department Power Output Test
VNUS has created a Biomedical Department Inspection Procedure for the testing of the VNUS RF
Generator. This procedure outlines setting the VNUS Radiofrequency Generator up in concert with an ESU
analyzer to verify temperature measurement, power output, and measurement of impedance.
A special test cable from VNUS is provided for this purpose. Please contact VNUS Customer Service for
informationonobtainingtheBiomedTestCable.(TL100-119-02Cable,BiomedTest).
Set-up Procedure
 • Check the RF Generator case exterior. The case exterior shall have no visible damage (e.g. dents,
scratches, scaled off paint).
 • Panel displays shall have no visible foreign material or damage.
 • Inspect all external connectors/receptacles for bent pins, foreign objects, damaged case and/or
improper fit.
 • The AC power cord shall have no obvious physical defects or damage.
 • Connect the RF Generator to the appropriate AC power supply and turn on main power,
wait until the generator completes its self- test.
 • Attach test cable to the generator.
 • The front panel parameters should be:
Temperature: ~23°C (ambient temperature)
Impedance: 1999Ω
Power: 0 W
 • Clip ESU tester to red and black leads. Select 100 Ω impedance on ESU analyzer.
 • Place red and yellow thermocouple wire in 37°C bath. Place reference thermometer in 37°C bath.
Test Method
 • Verify that the bath temperature and ESU analyzer load impedance are indicated on the Temperature
and Impedance displays.
 • Depress the“RF Power”switch to initiate RF power sequence.
 • Verify that the bath temperature, ESU analyzer load impedance, and power indicated on the
Temperature, Impedance, and Power displays on the RF Generator are in agreement with the
reference thermometer and the ESU analyzer.
 • Turn off main power to the generator. Remove the modified Instrument Cable from the RF Generator,
and AC power cord from the generator.
 • In assessing the functionality of the RF Generator with any external measurement system such as an
ESU Analyzer, the measurement tolerances of the ESU Analyzer for a given test must be added to the
tolerances listed in the Tolerances section of this manual.
Power Delivery Verification
This test is intended to verify the ability of the VNUS RF Generator to deliver RF energy.
 • Attach a ClosureFAST catheter (model CF7-7-60 or CF7-7-100) to the generator.
 • Fillaglasscontainerwith0.9%salinesolutionheatedto37±3°C(thissimulatesthetemperature
and impedance of blood in a blood vessel).
 • PlacethedistalendofthecatheterinsalinesuchthattheentireRFcoiliscoveredbythesaline.
 • Press the RF Power button on the generator to enter ready mode.
 • Press the Start RF button on the catheter to start RF treatment. Insure that the catheter coil is
covered by the saline while RF power is being delivered.
 • Verify that the generator delivers power and that the setpoint temperature is maintained during
delivery.
Alarm Priority
The RF Generator will generate a tonal alarm for an alarm condition based on the power, temperature,
and impedance feedback.
The RF Generator will enforce an alarm priority whereby an alarm message or tone takes priority over any
other type of message or tone (i.e. advisory and informational).
During multiple message or tone conditions, the message or tone with the highest priority will take
precedence as shown in Tables 7 and 8.
Table 7: Alarm Message Priority Table 8: Alarm Tone Priority
Priority Message Priority Tone
1 (Highest) Alarm Message 1 (Highest) Button Acknowledge Tone
2 Advisory Message 2 InvalidTone
3 Informational Message 3 Alarm Tone
4RF StopTone
5InformationalTone
6RF Start Tone
7RF OnTone
8 RF Pullback PauseTone
9Power OnTone

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14 VNUS Radio Frequency Generator
Error Codes
If an error occurs, the RF Generator displays an error code. An error will be one of two types:
unrecoverable or recoverable:
 • 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 VNUS Customer Service or a local distributor.
 • Recoverable errors require the operator to respond to an error message or make a clinical decision.
Table 9: Error codes
Error Code Description Corrective Action
Error 1 Unexpected state. Turn o the unit, wait a few seconds, and then turn on the unit.
Error 2 Unexpected event. Turn o the unit, wait a few seconds, and then turn on the unit.
Error 3 A parameter value was incorrect. Turn o the unit, wait a few seconds, and then turn on the unit.
Error 4 A queue overowed. Turn o the unit, wait a few seconds, and then turn on the unit.
Error 5 Unit not responding. Turn o the unit, wait a few seconds, and then turn on the unit.
Error 6 Software version incorrect. Turn o the unit, wait a few seconds, and then turn on the unit.
Error 7 Memory corruption detected. Turn o the unit, wait a few seconds, and then turn on the unit.
Error 8 Resource conict. Turn o the unit, wait a few seconds, and then turn on the unit.
Error 21 RAM failure. Turn o the unit, wait a few seconds, and then turn on the unit.
Error 22 UIC ROM failure. Turn o the unit, wait a few seconds, and then turn on the unit.
Error 23 UIC watchdog failure. Turn o 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 default RF Generator settings and make changes as desired.
Error 25 The inserted Multimedia Card (MMC) does not contain valid information or
is missing les.
Turn o the unit, wait a few seconds, and then turn on the unit. If
the error persists, try a dierent MMC.
Error 26
The inserted Multimedia Card (MMC)
cannot upgrade this RF Generator
because its serial number does not
match.
Turn o the unit, wait a few seconds, and then turn on the unit. If
the error persists, try a dierent MMC.
Error 27 The Multimedia Card (MMC) software
update failed. The RF Generator needs repair. ContactVNUS Customer Service or a local distributor.
Error 28 The inserted Multimedia Card (MMC) is not correctly formatted or is an
invalid type. Data logging will be disabled. No user action required.
Error Code Description Corrective Action
Error29 The RF Generator is unable to write
data to the Multimedia Card (MMC). Data logging will be disabled. No user action required.
Error 30 The inserted Multimedia Card (MMC) is full and no more data can be
stored on it. Data logging will be disabled. No user action required.
Error 31 The real-time clock stopped and has
been restarted. The operator should set the date and time. See the“RFG Setup Mode”section in the Operator’s Manual for instructions.
Error 32 The inserted MMC card is not
formatted. Replace the MMC card.
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 o the unit, wait a few seconds, and then turn on the unit.
Error 34 A UIC SoftwareTask did not check in
with theTask Monitor. Turn o the unit, wait a few seconds, and then turn on the unit.
Error 35 The RFG2 has experienced more than
ve resets in one minute. Turn o the unit, wait a few seconds, and then turn on the unit.
Error 36 A Software Stack became corrupt. Turn o the unit, wait a few seconds, and then turn on the unit.
Error 37 The temperature of the RFG2 is above
the specied operating temperature. Allow the RFG2 to cool down before use.
Error 38 The temperature of the RFG2 is below
the specied operating temperature. Allow the RFG2 to warm up before use.
Error39-
Error 485 Turn o the unit, wait a few seconds, and then turn on the unit. If the error persists, contact VNUS Customer Service.

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16 VNUS Radio Frequency Generator
Service and Maintenance
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 RF 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.
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
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.
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 back 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.
WARNING: Do not remove the cover of the RF Generator, as there is a potential for electrical
shock.
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 back of this manual for contact
information.
Opening the RF Generator by anyone other than an authorized VNUS technician voids the warranty.
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 :
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.
Fuse
holder
5 x20 mm
fuses
AC Power
switch
AC Power
inlet
Latch
Figure 6: Fuse Replacement

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18 VNUS Radio Frequency Generator
Technical Specifications
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.
Electrical
The RF Generator:
 • OperatesfromanACPowersourcerangingfrom100to240VRMS,50to60Hz.
 • IncludesaDIN42801–compatibleequipotentialgroundinglugthatmeetsthegroundbond
requirementsofUL60601–1.
Should the supplied power cord need to be replaced to match another plug configuration, the
replacement plug/cable/receptacle configuration must meet or exceed the following specifications:
100-120 VAC
- Cable: SJT16/3, IEC color code, maximum length 10 ft. (3 m)
- Plug: minimum 10 A - 125 VAC
- Unit receptacle: IEC female, minimum 10 A - 125 VAC
220-240 VAC
- Cable: H05VVF3G1.0VDE, maximum length 10 ft. (3 m)
- Plug: minimum 6 A - 125 VAC
- Unit receptacle: IEC female, minimum 6 A - 125 VAC
RF Power Delivery Performance
The fundamental frequency of the RF signal is set at 460.8kHz.
Tolerances
Displayed
Value
Range Accuracy Precision
Time 0:00-99:59
minutes:seconds ±1s ±1s
Temperature 10 - 130°C ±5°C ±19%
Power* 0.1 - 40 W ±20%
(@ 25-1000 Ω) ±1% (@ 25-1000 Ω)
Impedance 10-1999Ω ±15%
or ±5 Ω, whichever is greater ±8%
* RF Power is measured on the isolated patient circuit and is the average Real Power. The RF Power
capacity is also limited by the Maximum Power (W) setting of the connected RF Device. Please read the
RF Device’s Instructions for Use for more information.
0
5
10
15
20
25
30
35
40
0 200 400 600 800 1000
40 W
20 W
Power
Output
(W)
Impedance (Ω)
Figure 7: Power Output vs. Load Impedance

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20 VNUS Radio Frequency Generator
0
20
10
30
40
50
60
70
80
90
100
0 5 10 15 20 25 30 35 40
Peak Voltage (V)
Power (W)
Figure 8: Peak Output Voltage vs. Power Output
0
0
5
5
10
10
15
15
20
20
25 30 35 40
25
30
35
40
Power
Output
(W)
Max Power Set Point (W) @ 200 Ω
Figure 9: Power Output vs. Power Set Point

RM 55-441-01 REV.C
5799FontanosoWay
SanJose,CA95138USA
Tel: [phone]
TollFree:+1–888–797–VEIN(8346)
Fax: [phone]
Covidien Ireland Limited,
IDA Business & Technology Park,Tullamore
0123
Customer Service
Tel:[phone]
MEDICAL EQUIPMENT MODEL RFG2
WITH RESPECT TO ELECTRICAL SHOCK,
FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH UL60601-1
CAN/CSA C22.2 NO.601.1
75AK
®