RFG-3CF

LESION GENERATOR
OPERATORS
MANUAL

DOCS
RADIONICS' |==
MODEL RFG-3CF GRAPHICS RF LESION GENERATOR SYSTEM OUTPUT CONTROL OUTPUT SWITCH

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914-60-002 Rev. D

RADIONICS, INC.
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TITLE AND PUBLICATION NUMBER: Important Information.................... i

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Foreword
RFG-3CF Lesion Generator Operator's Manual
914-60-002 Rev.D General Information

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COPYRIGHT INFORMATION: Device Classification

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© 1997 by RADIONICS, INC., Burlington, MA Electrical Safety
All rights reserved.

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NOTICES:
This documentation contains confidential and proprietary information. No part of this document E
Chapter 1 Getting Started... 1

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may be disclosed, used, reproduced, stored in a retrieval system, or transmitted, in
any form or by any means, electronic, mechanical, photocopying, recording, or Description
otherwise, without the expressed written consent of Radionics, Inc. Contact your Intended Use
local Radionics distributor for additional copies. Unpacking the RFG-3CF

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Checklist of Components
TRADEMARKS:
Turning On and Testing the RFG-3CF

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RFG-3CF Radio Frequency Lesion Generator is a registered trademark of Radionics. All trade

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names referenced are the trademarks, registered trademarks, or products of their
respective manufacturers.
Chapter 2 Impedance Section... 5

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RADIONICS is a trademark of Radionics, Inc.
Test Mode Off
Test Mode On
The RFG-3CF (914) is compliant with the European Communities Council
C € Directive 89/336/EEC concerning electromagnetic compatibility.
Chapter 3 Stimulator Mtode.………………………………………………・ 7

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Test Mode Off
LIMITED WARRANTY: Test Mode On
Radionics warrants to the original purchaser that the equipment listed on page 2 shall be free
from defects in material and workmanship for a period of one year from the date of
shipment. Radionics' obligation under this warranty shall be limited to repair or
replacement at the option of Radionics, Inc. The above warranty is contingent upon Chapter 4 Lesion Mode... ο οσον 9
normal usage and does not cover products that have been modified without Radionics' Test Mode Off
approval or which have been subjected to unusual physical or electrical stress.
Test Mode On
Temperature Monitoring Electrodes: Since electrodes are more subject to abuse the warranty

a
differs. Barring mistreatment and misuse, if the electrode fails in the first three (3)
months after date of shipment it is replaced free of charge; if it fails within three (3) to
six (6) months it is replaced at 50% of its cost; and if it fails between six(6) to nine (9) Chapter 5 Temperature Monitoring................ 13

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months it is replaced at 75% of its cost. Thereafter RADIONICS discontinues its Test Mode Off
warranty. We note that with proper care TM and TC electrodes have and should
function for many years. A common problem is that the insulating coating may have Temperature
been scraped, in which case it can be recoated at RADIONICS. OTC -- Over-Temperature Control
Test Mode On

-----------
CAUTION:
United States law restricts this device to sale by or on the order of a physician.
MANUFACTURED BY: Chapter 6 Output Connections........................ 17
Radionics, Inc.
22 Terry Ave. Patient Connections
---

Burlington, MA 01803 USA External Connection

(617) 272-1233
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Footswitch
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AUTHORIZED EUROPEAN REPRESENTATIVE: €.

Analog Outputs
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Radionics Europe, NV Serial Output

Gentsesteenweg 40 $.
B-9230 Wetteren BELGIUM
+32-9-366-10-19
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Foreword:

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Device Classification

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Electrical Safety
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General Information

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Safe and effective lesioning is dependent not only on
Appendix D equipment design, but also on factors under the control of the
Specifications operator. Do not attempt to operate the RFG-3CF prior to
RFG-3CF Block Diagram completely reading and understanding the directions for use.

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Appendix E Warning: Electric Shock Hazard

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There are no user serviceable parts inside the RFG-3CF. To avoid
Accessories
“electric shock, return the device to Radionics for servicing. Refer to

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the service manual for maintenance and calibration instructions.

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“CAUTION”

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Warning: Hazardous Electrical Output

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This equipment is intended for use by qualified personnel only.
Do not use within 15 feet (4 meters) of a cardiac pacemaker.

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This equipment has an output which is capable of causing a

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physiological effect.

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Risk of Burns and Fire: Do not use near conductive materials such

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as metal bed parts or inner spring mattresses.

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Warning: Protective Earth Grounding

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Grounding reliability can only be achieved when the equipment is
plugged into a receptacle marked "Hospital Grade". Any

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interruption of the Protective Earth conductor will result in a
4 potential shock hazard which could cause injury to patient or
operator.
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Device Classification use of flammable anesthetics and nitrous oxide and oxygen

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should be avoided if a surgical procedure is carried out in the
Classifications as per IEC 601-1 /1988, the manufacturer describes the RFG-3CF as:

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region of the thorax or the head, unless these agents are
Type of protection against Electric Shock: ClassI suctioned away. Flammable agents used for cleaning or
disinfecting or as solvents of adhesives should be allowed to

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Degree of protection against Electric Shock; Type BF Defibrillator Protected
Degree of harmful ingress of water: Ordinary evaporate before the application of RF surgery. There is a risk
of pooling of flammable solutions under the patient and in

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Mode of Operation: Continuous Use
Degree of Safety in the Presence of body cavities. Any fluid pooled in these areas should be

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Flammable Anesthetic Mixture with Air, removed before the equipment is used.
Oxygen or Nitrous Oxide: Not suitable for use
Electrical Safety and EMC Warning: Apparent low power output or failure of the equipment to function

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correctly at normal settings may indicate faulty application of the
The Radionics RFG-3CF has been tested to and meets the reguirements of the
dispersive electrode or failure of an electrical lead. Do not increase
following Electrical Safety Standards: power before checking for obvious defects or misapplication.

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IEC 601-1 Medical Electrical Eguipment (1988) Effective contact between the patient and the dispersive electrode
must be verified whenever the patient is repositioned after the
IEC 601-2-2 Particular Reguirements for the Safety of High Freguency

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initial application of the dispersive electrode.
Surgical Eguipment (1992)
Warning: Set the output power setting as low as possible for the intended
The Radionics RFG-3CF has been tested to and meets the reguirements of the purpose.

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following EMC Standards:
Warning: Electromagnetic interference (EMI) produced by the RFG-3CF during

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IEC 601-1-2 Collateral Standards: Electromagnetic Compatibility (1993)
normal operation may adversely affect the performance of other
The following standards apply: equipment. The performance of this device may be adversley
affected by other high frequency surgical devices in close proximity.
CISPR 11 Group 1, Class A, ISM _If problems occur, separate the devices.
IEC 1000-4-2, 1000-4-3, 1000-4-4, 1000-4-5 Warning: The use and proper placement of dispersive electrodes is a key
Electrical Safety Information element in the safe and effective use of this lesion generator,
particularly in the prevention of burns. Read and follow the
The RFG-3CF is a radio freguency lesion generator designed
dispersive electrode manufacturer's instructions for preparation,

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to produce local tissue heating at the tip of an electrode by the
placement, surveillance, removal and use of any dispersive
presence of radio freguency current. Special isolation
electrode. The use of dispersive electrodes which meet or exceed

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transformers are imposed between power lines and internal
ANSI/AAMI requirements (HF18) is recommended.
RFG-3CF circuitry, resulting in very low leakage current.

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Warning: Use a large area for the dispersive electrode, preferably a large area
Warning: A needle electrode should not be used as the dispersive
gel-pad or similar “ground" plate to disperse and return RF current

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electrode, as it is possible to burn the patient at this site
over as large an area as possible, and thus minimize heating effects
due to high current densities. In all applications, care

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at that electrode. Use broad ground plates or gel pads as dispersive
should be taken to maximize the surface area of the
electrodes to avoid high current densities and resultant burns in
dispersive electrode. The dispersive electrode should SS UL
adjacent tissue.
be reliably attached with its entire area to the patients
body and as close to the operating field as possible. The ground pad should be placed in close proximity to the lesion
site (e.g., for head and neck procedures at the scapula and for lumbar
MR)

The risk of igniting flammable gases or other materials is and thoracic procedures at the legs. Never place at the gluteus
inherent in lesioning and cannot be eliminated by device maximus).
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design. Precautions must be taken to restrict flammable

materials and substances from the electrosurgical site. The
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Warning: Observe the dispersive electrodes during lesioning for signs of Warning: Never proceed in a temperature monitored procedure if the
excess heating. generator does not read body temperature before you begin
delivering RF energy.
Warning: The long-term risks of protracted fluoroscopy and creation of RF
lesions have not been established. Careful consideration must Warning: Raise the temperature slowly, particularly with large electrodes.
therefore be given for the use of the device in prepubescent Displayed temperature lags behind the actual temperature due to
children. Furthermore, the risk/benefit in asymptomatic patients the thermal mass of the electrode.

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has not been studied.
Warning: The stimulator should not be used in any situation where the

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Warning: The RFG-3CF is capable of delivering a significant amount of stimulating electrode could potentially come in contact with heart
Patient or operator injury can result from improper muscle, since these low frequency pulses could cause a serious

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output.
handling of the active electrode and dispersive electrode, o physiological effect.
delivery ,

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particularly when operating the generator. During energy Warning: Verify functional safety of the device before each use.
should not be allowed to come in contact with metal

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the patient

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“parts which are earthed or which have an appreciable capacitance to
use of antistatic sheetingis recommended for this Caution: Increase temperature at a slow and steady rate to prevent
earth. The

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purpose. Unshielded leads (active or return) should be positioned temperature overshoots.
so that they cannot come into contact with the patient or other leads

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connected to the patient and so that they do not run parallel to Caution: Concentrate on maintaining the desired temperature response. If

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-© nearby leads. you cannot get a temperature rise, the voltage and current meters
will indicate if the problem is an open circuit (abnormally low

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Warning: r -to-skin contact should be avoided to prevent the possibility of current and high voltage) or short circuit (abnormally high current
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“accidental burns. lt is recommended to place gauze pads in probabl and low voltage).

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| skin-to-skin contact sites (e.g., armpits, etc.).

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Warning: ‘Electrodes and probes of monitoring, stimulating, and imaging Notice: Always have spare electrodes and cables on hand in case a problem
devicesの やつのcan provi nts even if they arises with the first one during a procedure.

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The risk of burns
Notice: Reusable cables and accessories should be periodically function and

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safety tested. Position cables to avoid contact with the patient or
other leads.

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Warning:

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Warning: © Always inspect insulated electrodes and cables for damage before
each use. If an electrode or cable has cracked or scraped insulation, м
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© RF current will flow out these cracks and not be concentrated at the
tip. This can cause an abnormal temperature rise and abnormally
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© high current and low voltage readings on the meters (similar to a

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short circuit).
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 Chapter 1
Getting Started
IMPEDANCE LESION TEMPERATURE

STIMULATION AMPLITUDE

RADIONICS: αλ. ZA

MODEL RFG-3CF GRAPHICS RF LESION GENERATOR SYSTEM OUTPUTCONTROL OUTPUT SWITCH

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POWER

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Description
The RFG-3CF is a microprocessor-based lesion generator
capable of supplying up to 50 watts of radio freguency power
while continuously monitoring both the tissue impedance
and the temperature at the tip of the selected electrode. It
contains a stimulator section to facilitate the proper
placement of the electrode before lesioning. Additionally,
there are several built-in features, such as an over-
temperature control and audio tones that indicate impedance
and temperature values. Finally, the status display indicates
the mode and gives other important information, such as
open circuit, temperature over boiling, etc. All of these
functions are described in more detail in subseguent chapters.

Intended Use
The RFG-3CF is intended to create lesions in nervous tissue.
It is indicated for use in neurosurgery, orthopedics, and
podiatry.

Unpacking the RFG-3CF

Box 1 contains:
RFG-3CF
Operator's Manual and test records.
The RFG-3CF is packed surrounded by foam in a double-
walled box. Remove the top foam and lift out the unit by the

Getting Started 1
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handle. Place the Operator's Manual and test records in a safe Press the TEST button. The button should illuminate and
the status window should display TEST MODE ON, SELECT

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place for later reference.
MODE. The impedance meter should read 100% +20%. Both

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Notice: Save packaging materials for use in the event that the

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the analog and digital temperature meters display the
RFG-3CF is shipped back to Radionics.
temperature of the test resistor inside the RFG-3CF,

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Cables and additional accessories are packed in Box 2. approximately room temperature.

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Box 2 contains: Notice: If the temperature is less than 20°C the display reads

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RFG-3C-TB Tool Box " u

C119, C118-F, or C120 Power Cord, depending on destination

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C104-TM Connecting Cable for TM Electrodes Press the STIM button. It should illuminate. Set the Output

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C121 5' Black Reference Cord Control knob to zero. The Stimulator section windows

一. 一

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(2) SK-1R Red-Anodized Sterilizable Knobs should display approximately 0 volts, 50 Hz rate, 1.00 ms
duration, and the "V" LED will be illuminated, indicating

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(2) Spare Fuses CON-FU-0042 (1.6A or -0045 (3A)

一一 一

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RFG-GP-S Grounding Pad w/Shrouded Plug (International voltage stimulation mode is selected. The status window

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Sales only) should display TEST MODE ON, STIM MODE READY. If the

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RFG-3C-FS-1 Footswitch (Waterproof) knob is not set at zero, the display reads TEST MODE ON, SET

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CA-TC TC Active Jack Adaptor. CONTROL TO ZERO. Depending on the position of the

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Output Control knob and the Stimulator range toggle switch,
Turning on and Testing the RFG-3CF the stimulator voltage reads approximately 0-1 volt in the
low range and approximately 0-10 volts in the high range.
After unpacking the RFG-3CF from the shipping box, plug
the power cord into the rear of the unit. Turn the Output Control knob to Min, and depress and hold

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the footswitch. The ON button should light, the Rate LED
Caution: Make sure that the wall outlet voltage and frequency

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should begin to flash, and the status window should display

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match those on the serial number label on the rear of TEST MODE ON, STIM OUTPUT ON. Release the footswitch

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the unit.
to change settings.

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Plug the power cord into the proper AC receptacle. Rotate the

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Press the RATE button to change the rate setting. Press the

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RFG-3CF's carrying handle downward by pressing the buttons RATE button repeatedly; the speed of the LED flashes changes
on both sides of the handle. The handle will lock into a

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correspondingly. Press the DURATION button repeatedly to
number of different positions to allow it to be used as an

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change the duration setting. Select One Shot mode by

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adjustable tilt stand as well as a carrying handle. Adjust this toggling the RATE SELECT button until dashes are displayed
handle for easy viewing of the front panel. in the Frequency window. The Rate LED should stop

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flashing, the status display should read TEST MODE ON, and
Notice: No electrodes or cables should be connected to the
unit should switch to output off. The Rate LED flashes once

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RFG-3CF.
each time the footswitch is pressed.

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Connect the footswitch to the rear panel for this test. Press Press the MODE button to deselect One Shot mode and select
the green POWER switch. The RFG-3CF performs the NNN om Current Stimulation mode. The mA LED will illuminate in
following self-tests: RAM test, ROM test, and a display test.
During the display test verify that all LED's are lit. If any LED A the Stimulation window, indicating Current Stimulation
mode is selected. Use the RATE button to select 5 Hz. The
is not functioning, do not use the device and call Radionics.
NIN

Output Control does not have to be set to Min. Depress and

The Status window should read OUTPUT OPEN CIRCUIT,
hold the footswitch. The ON button should be illuminated,
SELECT MODE. The Temperature and Impedance LED
the Rate LED begin to flash, and the Status window display
displays should read "---". The green light above TC1 should
Ind,

TEST MODE ON. Release the footswitch to change settings.

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light.
MANN

Getting Started 3
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2 RFG-3CF 914002
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Press the LESION button. The button should illuminate, and
the LESION TIME window should display the set time.
VOLTAGE, CURRENT and WATTS should read zero. The

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status window should display TEST MODE ON, LESION Chapter 2
MODE READY. If the output control knob is not already set

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at Min, the window will display TEST MODE ON, SET Impedance Section

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CONTROL TO ZERO. The OFF button should be lit. If the
OTC toggle switch is in the ON position, the Automatic Over- IMPEDANCE
Temperature Control window indicates the over-
temperature set point. If the toggle is OFF, the window is OHNS (2)
blank. IMPEDANCE

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KILOHMS (KO)

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Place the Lesion Timer Control switch in the OFF position to (ON ALARM
perform this test. Turn the SET TIMER knob to zero. The

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timer window displays 00 or 01 sec. With the knob at its VOLUME I

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maximum setting, the TIMER display should read between STATUS
115 and 120 sec.

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Move the OTC toggle switch to the ON position and turn the

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temperature knob to 20 degrees. The OTC window should

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display between 15 and 25 degrees. Turn the knob to its

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maximum setting. The display window should read between
95°-100°C. Move the OTC toggle switch to the OFF position. RADIONICS®

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MODEL RFG-3CF GRAPHICS RF LESION GENERATOR SYSTEM
Turn the Output Control knob to Min. Press and hold the

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footswitch. Turn up the Output Control knob until the RF POWER DOCUMENT

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VOLTS display reads 50 volts. The RF current display should
read approximately 500 mA and the RF watts display should DOC TEST ||| STIM || |LESION

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read 25 watts. If the RF power is left on long enough, the test
resistor will begin to heat up. This can be seen by an increase

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in the Temperature meter reading. Release the footswitch.

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Test Mode Off
Push the Electrode Select button. The TC2 electrode is

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selected, and the green light moves to above the TC2 jack. The RFG-3CF continuously measures the impedance between
Press the button again. The TM electrode is selected, and the the selected electrode and the dispersive electrode. The

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green light above the TM jack illuminates. If pressed a third appropriate ohms (Q) or kilo-ohms (kQ) LED will light. If the
time, the TC1 electrode is selected and the green light above measured impedance exceeds 5,000 ohms, the Impedance

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the TC1 jack again illuminates. window will display dashes (---), and the status window will

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display OUTPUT OPEN CIRCUIT. There is also an audible
Push the TEMPERATURE TEST button. The temperature tone that is proportional to impedance when not in lesion
display and the analog meter should read approximately 40 UU
ABRAM
mode (the tone is proportional to the temperature when in
degrees and then change to 90 degrees after a few seconds. Lesion mode). The volume can be adjusted by turning the
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Repeat for the TC2 and TM electrodes. Volume knob.

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The preliminary test of the RFG-3CF is complete.

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Contact your local Radionics distributor if you have any

guestions.
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4 RFG-SCF sue Impedance Section 5

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Notice: Confirm the TEST button is not illuminated when

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attempting to deliver energy to an electrode.
Otherwise the energy is delivered to the internal test
load, and no energy is delivered to the tissue.
Chapter 3

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Test Mode On Stimulator Mode
The test resistance is 100 ohms +20%. Whenever the test
C STIMULATOR ον
button is pushed, the status window displays TEST MODE

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ON, and the Impedance window should display

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approximately 100 ohms.
STIMULATOR AMPLITUDE

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PULSES
PER
SECOND
RATE

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SELECT O O MODE

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PULSE MILLI-
| DURATION
0-10
SECONDS

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DURATION O STIM
SELECT 0-1 RANGE
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Test Mode Off

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| The stimulator is selected by depressing the yellow STIM
mode button.

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s! Voltage or Current stimulation mode is selected by

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s! depressing the MODE button. The "V" or "mA" LED will
illuminate, indicating which mode is selected.
u! The pulse amplitude is displayed in the Stimulator

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εἰ Amplitude window. It is increased by turning the Output
εἰ Control knob clockwise.

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E| UVU The pulse frequency is indicated in the Pulses Per Second
window and is changed by pushing the Rate Select button.
g | When the stimulator is activated, the RATE light flashes at
the selected rate as an indicator that the stimulator is
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e working.
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«| The pulse duration is indicated in the Pulse Duration

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window and is changed by pushing the Duration Select

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6 RFG-3CF 9146002 Stimulator Mode 7

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button. Selecting the One Shot mode sends a single pulse to ES ES
the output each time the stimulator is activated. One Shot |
mode is selected by depressing the RATE SELECT button ENS
until dashes are displayed in the Pulses Per Second window. E | 3 Chapter a

The stimulator is activated by depressing and holding down | Lesion Mode

the footswitch while in STIM mode. The microprocessor Е | 5
prevents the stimulator from being turned on when in E に —— LESION
Voltage Stimulation mode without first setting the Output | S
Control knob to Min. E 3

The stimulator can be turned on independent of the Output = 3

Control Knob position when Current Stimulation mode is E 1 3 SE ER TIME IN SECONDS
selected. ' 60 RESET ON . OFF
Lo 30/90
Notice: Note that the readings of the stimulator voltage or Е | 3 SEC 0 7120
current, pulse frequency and pulse duration indicate e 3 LESION TIMER CONTROL
their respective settings only. A value shown for pulse | RF
amplitude does not mean an output is being produced. E y POWER WATTS
The status window displays STIM OUTPUT ON and |
the rate light flashes when a stimulus is sent to the Ε | 3 OUTPUT VOLTS
output. E:3 VOLTAGE
Notice: In Current Stimulation mode dashes are displayed,
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indicating the impedance is too high to maintain a
Rg|| RF
OUTPUT
CURRENT
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AMPS
constant current. This is corrected by lowering the = gl
stimulation current. Е | a

Test Mode On
The functions are identical as described above, except the
JE| | Test Mode Off
| |
Select Lesion mode by pressing the LESION mode button
output is directed to a 100 ohm internal test resistor instead of F'3 until it illuminates.
the selected electrode jack. É | 3 The lesion timer indicates lesion time in seconds and, if
| activated, counts up from zero to the set time, then disables
fig the RF output. The timer can be set between 0 and 120
sia ~ seconds ds by turning
turning the
the SET TIMERknob
nob in ınthe
the Lesion
Lesion Ti Limer
| " Control section. Pushing timer RESET resets the timer to
Е | 3 zero.

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vd If the
the lesioning
lesioning isis aborted
aborte pririor to the
he titimer disabling
disabling the
the RF
| output, the elapsed time freezes on the timer window until
| 건 3 the RESET button is pressed or the output is reactivated.
Ея The lesion timer is enabled by moving the ON-OFF toggle
| switch to the ON position, and is disabled by moving it to the
Es OFF position.
& 3 The timer actually starts timing (if enabled) when the
ε. 3
8 RFG-3CF 914002 È | a Lesion Mode 9

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footswitch is pushed. It may also be enabled or reset at any

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time after the lesion power is turned on.
. . . Resistance vs. Power
Turn on RF power by pushing the footswitch. The power is
increased or decreased by turning the Output Control knob. 80
The micro-processor prevents turning the RF on when the o Output Control
Output Control knob is set above Min. The RF output cod + 5 Halt

Output Power in Watts

current, volts and power are displayed in their respective 4

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+ testes D Full

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windows.

405 k

4
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Test Mode On

4
The functions are identical to those described above, except
the output is directed to a 100 ohm internal test resistor

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instead of the output jacks.

14
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『 i | 1 【 i 1 ! т 1 1 1 i i 1 | i I i
05 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19

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Resistance in K Ohms

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Power vs. Load Resistance
E: 80

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E: 70 - Resistances

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E: | Output Control Knob Setting

Е: | IMPORTANT NOTE: Output power varies with mains voltage +20%. These
| | readings were taken on a 240V/50Hz unit at 240Vac-. The output power
Bi, displayed in the above graphs is the measured, not the displayed, value. The
E | displayed value may vary by +10%.
snr”

10 RFG3CFP ouz Lesion Mode 11

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ZE Chapter 5
[This page intentionally left blank.] t y Temperature Monitoring

E y (TT TEMPERATURE TTT ~

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E 3
E 1 J TIP TEMPERATURE IN C° TIP
TEMP
Eg- TEMPERATURE TEST で
. (AUTOMATIC OVER-TEMPERATURE CONTROL
E 34 SET
E 3 NED OPTIONAL |
E | TIP TEMP
| IN °C
E |3| 3 bo 20° o,
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O” ON
OFF
6 3
『 3
|

E 3 Test Mode Off

E: | 3 Temperature
É | 3 Temperature is displayed in the tip temperature window and
fia indicates the tip temperature (°C) of the selected electrode.
| Pressing the Temperature Test button performs a 40° and 90°
Е: | 3 test of the circuitry chosen by the Electrode Select button. The
fi | 3 measured output is displayed in the temperature window
| | and on the analog meter so that a functional testanda
fg calibration check can be performed at any time. It is
| considered acceptable if the temperature displayed is within
gs 4 +2 °C of actual value, i.e., 38-42° for 40° test and 88-92° for 90°
| test.
$. 3
ni OTC -- Qver-Temperature Control
E 3
i 3 The OTC prevents the selected electrode tip temperature
& from exceeding the preset temperature displayed in the over-
& 3 temperature control window. If this temperature is exceeded,

u 3
12 REGSCF sumo E 3 Temperature Monitoring 13

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 =

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3
the amplitude of the RF power is reduced slightly. This is E y Test Mode On
done by a feedback mechanism that regulates the temperature 5
at the preset value. However, this is only true if the set yg When the TEST button is illuminated, the temperature
power is between the set temperature and 5° higher than set displayed is the temperature of the internal thermocouples or
temperature. If the latter occurs, the status displays POWER ES thermistor (depending on which electrode type is selected).
SET TOO HIGH, and the alarm sounds. The Over- È O This allows testing of the RF generator, temperature circuitry,
Temperature Control can be set between 20°-100° with the Set and OTC if desired. All other functions are as described in
Temperature knob. Note that the OTC circuit is activated E y Test Mode Off.
only if the OTC toggle switch is in the ON position. If it is in
the OFF position, the set temperature window is blank, and E 3
the operator must manually adjust the Output Control knob E y
in order to maintain a desired temperature.

The OTC can be used in two different ways. ey

1. The OTC can be used to protect against the tip temperature E-3
rising significantly higher than the desired lesioning € y
temperature. For example, with the set temperature at 90°C, |
the over-temperature control prevents boiling from E 3
occurring. Similarly, if the lesioning temperature was to be E
80°C, set the over-temperature control at 85°C. The RF power E,
would then be turned up and controlled by the surgeon, but E 3
would automatically engage if the temperature rose above
85°C. E 3
2. The OTC can also be used as an automatic temperature E 3
control. Set the over-temperature control at the desired |
lesion temperature and slowly turn up the RF power until ε 3
the set temperature is reached. The microprocessor now E 3
regulates the RF power to maintain this temperature. o
E
Notice: When using this mode, the temperature can vary +2°C | 3
from the set temperature. The microprocessor is E 3
setting the correct amplitude and is reacting to the
thermal time constants of the tissue. If the RF power is E 3
too low, the OTC does not activate, and the lesion E 3
generator functions as all previous models. If the RF -
power is turned up so that boiling occurs, the RF is = 9
turned off and a warning appears in the status _
window. E 3

E 3
Eg
E 3
& 3
E 3
14 RFG-3CF season Е a Temperature Monitoring 15

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Chapter 6

LL LE FZ LU
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[This page intentionally left blank.] Output Connections

О [0+=0-—0-—0-| ©

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REFERENCE {XL Г > İİ 9 ©

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room
to qem
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Patient Connections

mm
Type BF defibrillator protected.

morir

ws
1 F Neutral Electrode isolated at low and high freguencies.

[F] Patient connections are made via two output jacks marked
"Reference". Either one may be used to accept the dispersive

Www
electrode plug. Electrode jacks are selected by repeatedly

m
pushing the electrode select button until the desired LED
lights.

m
External Connection

momo onoeom

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Three things happen when the External Connection button
© is pushed:
1.

U
The button illuminates.
2. The status window displays External Connection.

U UU
3. The external connection jack is connected to the selected
electrode.
Use the External Connection button to connect an external
device to the tip of the electrode without removing the
electrode or the cable from the patient or the device.
U
one.

Warning: Any device connected to the External Connection jack

must be of at least type BF Protection Against Electric
E

Shock and meet the requirements set forth in IEC

601-1-1.
NN
U
U
U

16 REGSCF sumo
Output Connections 17
ÚM
=
 Ба
E 3
Footswitch E 3 | Notice: The printer must use the HP* PCL command set.

The RFG-3CF is supplied with a footswitch of the momentary Ба

Y type. The footswitch must be plugged into the jack marked The following printers have been tested with this unit.
FOOTSWITCH on the rear of the unit. The RF output may E 3 1. HP LaserJet
only be activated by depressing and holding the footswitch. 2 . HP Laserjet IP
RF output is deactivated when the footswitch is released. E a 3 . HP LaserJet 11P Plus (with optional serial interface)
4 . Okidata 830 in HP emulation (with optional serial
Analog Outputs (DC Volts)
Eq interface)

Analog output BNC connectors are supplied on the rear of Es The connector is configured as shown below.
the RFG-3CF for Impedance, Temperature, RF Watts, RF E 3
00000) | mo
b

Current, and RF Volts. The outputs are adjusted to 1volt DC

for full scale reading; this is a standard input for most chart Es o(99999/0 sora
recorders.
Eg All other pins N/C

Notice: Always record the wattage readings that correspond to

a given temperature for a given technigue. This gives E 3 *HP is a registered trade mark of Hewlett Packard
extra guidance and helps Radionics diagnose problems. E 3
It is recommended that analog recordings are made for
as many parameters as possible to provide data when
E A
guestions arise. At minimum, İmpedance, Е а
Temperature (if being used), and Watts should be
recorded. SE
ка
ΕΝOD DUDU UUOOD DUDU " F 3
IMPED TEMP
RF
WATTS
RF
CURR
RF
VOLTS ка
9 [00000 Е 3
o 0 o o
E
ка
O1VDC o1VDC O1VDC 01fVDC 0C1VDC
o o © Y GFS 20-100C G100W GIAMP G-100V
FOOTSWITCH SERIAL
e ху ο ο
O ~ pa
“> =
ОО ° 9 0
ς3
Fg
o o 0
o ο NZ o

E. 3
ε. 3
Serial Port
A serial output is provided on the back of the unit. This
A output conforms to the RS232C serial output configurations.
NY If a LaserJet printer is serially connected to the 9 pin output E 3
connector on the back of the unit, a graph of the front panel
settings versus time is printed by pressing the DOC button.
Ga
κ.3

6. 3
18 RFG-3CF 0148000 € 3 Output Connections 19

5:3
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Appendix A
[This page intentionally left blank.] Sterilization, Care, Service

m
mm
Sterilization

Caution: It is recommended that all cables and electrodes be gas

sterilized (ETO). The cables may be standard (gravity)

m
autoclaved (121°C).

e
The sterilizable knob may be flash autoclaved (132°C).

m
No other parts may be autoclaved.

mam

II
Care

The RFG-3CF may be cleaned by wiping with a soft cloth

ma
dampened with a mild detergent. Do not allow liquid to get
into the generator.

ma
The cables, electrodes, and cases may be wiped with mild

mam
cleaning solutions, taking care to keep moisture out of the
connectors. Store in a clean, dry, and non-corrosive
atmosphere. The lesion generator is designed to withstand

mam
all normally encountered environmental conditions. Do not
drop or bang the lesion generator.

Service

"nu
Caution: The RFG-3CF is not user serviceable, and the generator
should be returned to Radionics if any problems arise.

To ensure accuracy of unit output and displays, return the

unit to Radionics for yearly calibration.
In case of failure or malfunction of the device, discontinue
т use and report the failure or malfunction to Radionics.
For any electrical malfunction, accident, misuse, alteration or
т

other damage, return unit immediately to Radionics with a

problem description.
Contact Radionics Customer Service for further assistance if
m

needed.
m

20. RFG-3CF 014400

Appendix A A-1
全
 v ne
Fuse Replacement

A Warning: Risk of fire. Fuses must be replaced as marked.

Appendix B
The RFG-3CF has two fuses, one for line and one for neutral Troubleshooting
conductors. Replace with:
3.0A 250V for 100V-120V line operation. Troubleshooting
T1.6A L 250V for 220-240V line operation.
PROBLEM POSSIBLE CAUSE
("T" indicates slow blow or time lag fuse.)
Unit will not turn on Bad AC outlet
Defective power cord
Blown fuses
No output Unit in TEST MODE
No ground connection
Problem with electrode
Break in electrode cable
Wrong electrode selected
No impedance readings No ground connection
Open circuit in cabling

A
RF output will not turn on Time set to zero

人
Output control set to a value
other than zero
Footswitch defective
Power shuts down Set time on the timer is
prematurely too low
No response when a Button is stuck in the
button is pressed depressed position.
No temperature reading Not using temperature
monitoring electrode.
Bad cabling or electrode (can
be verified if RFG-3CF
passes TEMPERATURE
TEST)
Stimulator voltage too low Range switch in low position
Stimulator will not turn on Output control off zero
Lesion output power low OTC set too low
and alarm sounds

A-Z RFG-3CF 01460002 Appendix B A-3

=

4
 ma
Warning: A COMMON PROBLEM THAT OCCURS DURING
TRIGEMINAL NEURALGIA (TIC) PROCEDURES IS
THE PATIENT MAY EXPERIENCE A STIMULUS
EVEN WHEN THE GENERATOR IS UNPLUGGED Appendix C
FROM THE POWER SOURCE.
BNIC Chart Recorder
This occurs because the patient acts as an electrolyte,
and when two plates of dissimilar metals (electrode Calibration
and ground pad) are attached, a battery is formed. Ifa
discharge path is connected across this voltage, the
charge carriers present will flow through it, BNC Chart Recorder Calibration
discharging the potential. This is the case when a
RF RF RF
lesion generator is connected across a patient via an IMPED TEMP WATTS CURR VOLTS
electrode and ground plate. This discharge action may

d à à eu
stimulate the patient if near the trigeminal nerve.
Use an electrode and ground plate composed of the
same metals to remedy this. No significant charge
develops across them when connected to the patient,
and no current flows when connected to the generator. 0-1VDC 0-1VDC 0-1VDC 01006 01006
0-FS 20°-100°С 0-100W 0-1AMP 0-100V
Radionics, Inc. will supply (international only) , by
request, a stainless
with Radionics steel ground pad [RFG-GP] for use
electrodes. The following equipment is needed for this calibration:

If unable to resolve the problem, contact Radionics one 5kQ 1/4 watt 5% resistor
Technical Support. one C102-B black reference cord
one lesioning electrode and cable

Procedure

IMPEDANCE

1. Connect the chart recorder to the IMPED BNC connector

on the back of the RFG-3CF.
2. Connect the electrode and reference cords to their
respective front panel jacks.
3. Connect the ends of the cords together.

Caution: DO NOT TURN THE RF ON WHILE THE CORDS

ARE SHORTED.

Turn the RFG-3CF and the chart recorder on.

ле
Adjust the chart recorder zero control until the pen
reads zero.
6. Connect the electrode and reference leads from the unit
to the 5kQ resistor.
7. Adjust the chart recorder gain control for full scale
reading.

AA | RFG-3CF 01460002 Appendix C A-5

bi,
 4
тя
8. Remove both of the cords. reads zero.
Adjust the Output Control knob until the volts display
TEMPERATURE reads 50V.

m
1. Connect the chart recorder to the TEMP BNC connector Adjust the chart recorder gain control until the pen

m
on the back of the RFG-3CF. reads half scale.
2. Press the Temperature Test button on the front panel.
3. When the temperature display reads 40°C, adjust the

mm
chart recorder zero for the position that you want the 40°
line.
4. When the temperature display reads 90°C, adjust the

m
chart recorder gain for the position that you want the 90°
line.

mmm
WATTS
1. Connect the chart recorder to the WATTS BNC
connector on the back of the RFG-3CF.
2. Adjust the chart recorder zero control until the pen

mem
reads zero.
3. Press the TEST button on the front panel of the unit to
put the unit into test mode.

Mm
4. Press the LESION button to put the unit into lesion

ΠΠ
mode.
5. Switch the timer ON/OFF switch to the OFF position.

n om
6. Turn the Output Control knob to zero and press the ON
button.
7. Turn the Output Control knob up slowly until the
WATTS display reads 40.

mnm
8. Adjust the chart recorder gain control until the pen is
where you desire 40 watts (near full scale).
9. Turn the Output Control knob to zero.

nn
CURRENT
1. Connect the chart recorder to the CURRENT BNC
connector on the back of the RFG-3CF.

mnm
2. Turn the chart recorder zero adjust until the pen reads
zero.
3. Turn the Output Control knob up until the Current
display reads 500mA.
m
4. Adjust the chart recorder gain control until the pen
reads half scale.
n

VOLTS
n

1. Connect the chart recorder to the VOLTS BNC connector

nn

on the back of the RFG-3CF.

2. Adjust the chart recorder zero control until the pen
nn

AS REGSCF sum Appendix C A-7

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 «4 LE
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4
Ad
Appendix D

a
[This page intentionally left blank.] Specifications
RFG-3CF Block Diagram

EEK
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Specifications for the RFG-3CF Lesion Generator
ELECTRICAL SUPPLY
Voltage Specifications: Volts (customer specified) Volts input range
100Vac 90-110

EEK
117Vac 105-125
220Vac 200-240
240Vac 220-260
Maximum input voltage: 260Vac
Maximum voltage on
any output connector: 260Vac

YUOAMA
Maximum input power: 416VA
Supply current: 3.0 AMP ~ alternating current sinusoidal wave
(117V units)

NN
1.6 AMP ~ alternating current sinusoidal wave
(220V units)
Fusing: 3.0 AMP (T) Time-lag (117V units) Domestic

OU
1.6 AMP (T) Time-lag (220/240V units) Foreign
Frequency: 50/60 Hz

NNN
ENVIRONMENT OPERATING RANGE
Temperature: 50°F-86°F
Humidity: 20%-80% Non-condensing relative humidity

YAA
Atmospheric Pressure: 500 hPa - 1060 hPa
IMPEDANCE MONITOR
Range: 0-5000 ohms digital

MN NNN
Resolution: 1 ohm
Accuracy: 10% of full scale
STIMULATOR OUTPUT
Rate: ONE SHOT, 2, 5, 10, 20, 50, 75, 100, 150,
180, 200 Hz
Duration: .1,.2, .5, 1.0 ms

AE
Amplitude selectable:
Voltage stim mode: 0-1 volt

E
0-10 volts

MEN
Constant Current

U
stim mode: 0-1 mA
0-10 mA

EU
NT

RF LESION GENERATOR OUTPUT

Timing: Selectable: 0-120 seconds
Accuracy: .25 second
Resolution: +1 second
ULU
AN

Volts: 0-100 V
Accuracy: 10% of full scale
Resolution: +1 volt
Current: 0-999 mA
Accuracy: 10% of full scale
NN

AS RFG3CF 155000 Appendix D A-9

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1
Eğ
Resolution: 1 mA -
Watts: 0-50 watts Max. (40 watts min. into 10002 load) k 里 Block Diagram of the RFG-3CF
Accuracy: 10% of full scale ーー
Resolution: 1 watt E a 은
Frequency: 500k Hz + 10% - >
TEMPERATURE MONITOR E 3 2
TC1, TC2, and TM drift less than +2° from ambient temperature E -O
OVER-TEMPERATURE CONTROL y
Range: TC1, TC2, and TM 20-100°C € y ‘OSO 42)
Resolution: +1°C | |
OUTPUT JACKS (BNCs on back panel) E y |
RF Volts 0-100 RF volts 0-1 Vdc +/-20% FS | © Apey DI
RF Current 0-1000 RF mA 0-1 Vdc +/-20% FS s y 3 | | し |
RF Watts 0-50 RF watts 0-.5 Vde +/-20% FS 을 | — |
Impedance 0-5000 ohms 0-1 Vdc +/-20% FS = 23 | | L て |
Temperature 20-100°C 0-1 Vdc +/-20% FS E- + 오유 ору O o ©
-
Eğ B ||
5 ーーーーーーー
А | | ーー (BES!
一 9 95
Е enloleduue」 に] |2 8 |
Notice: The above voltages are nominal since exact т | mě
calibration is achieved by adjusting the offset EX Ds | souopedu [I O
and gain controls on the recording device to | 5 sê | ©
which this is connected. E 7 | = о 2 | | <

E 3 一 -一 O
LA IL

E 4 © , TN, © \ LU
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E q R — ビ / < | |

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一 一 Addons
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55
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Eo 3 = |
INC GND || LU
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20
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E 3 E
F 3
|| | Bopuojom
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Ea| a =o 1 i
mm |
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= 一一 Гы
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IN: mm
|
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FE A IQ | JosseooJd 下 с
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F 4 一 — 一 (一
F 4
к 4
κ 4
A-10 RFG-3CF o10000 A A Appendix D A-11

5.3
 e
a
Appendix E

[This page intentionally left blank. ] Accessories

A
Radionics Part No. Description
C104-TM Thermistor Style Electrode Cable
C111-TC Thermocouple Style Electrode
Cable (low power)
C112-TC Thermocouple Style Electrode
Cable
RFG-3C-FS-1 Footswitch (waterproof)
RFG-DGP Grounding Pad (disposable)

W ll li
RFG-GP-S RFG Ground Plate
C118-F Foreign Power Cord (foreign style,
230 volts)
SRK-14 Thermistor Style Electrode

U
TEW Thermocouple Style Electrode

A
RFG-3C-F(1.6) 1.6 Amp Fuses (220/240V units)

W
RFG-3D-F(3.0) 3.0 Amp Fuses (100/120V units)

ω
A
©
©
©
©
à
à
ο...
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a
a

Appendix E A-13
a

A-12 RFG-3CF 01800

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