Gyrus ENT G1 Temperature-Controlled Radio Frequency Generator User Manual July 2010

This user manual will familiarize you with the controls and output functions available from your Gyrus ACMI G1 TCRFTM Generator and instruct you on its proper use. Gyrus Group, PLC. 2007. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, stored in retrieval systems, or translated into any language or computer language, in any form, or by any means: electronic, mechanical, magnetic, optical, or otherwise, without the prior written permission of Gyrus.

Patents

This product may be covered by one or more of the following patents: 5,843,021; 5,820,580; 5,817,049; 5,800,429;5,746,224; 5,730,719; 5,944,715; 6,004,319; 6,013,076; 6,015,406; 6,045,549; 6,056,746; 6,074,386, 6,090,106, 6,093,186; 6,152,143; 6,131,579; 6,179,803; 6,210,355; 6,210,405; 6,228,081; 6,234,178; 6,261,286; 6,293,942; 6,303,134; 6,364,877; 6,416,491; 6,416,509; 6,482,202; 6,517,535; 6,371,926; 6,682,501

Gyrus ACMI Electrosurgical Generator (TCRFTM) USER MANUAL Gyrus ACMI Part No: 135015-FB

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Copyright

LIMITED WARRANTY

The warranty periods for the components of the Gyrus ACMI G1 TCRFTM Generator are as follows: Component

Warranty Period

Generator and footswitch

One year from shipment date

This warranty is in lieu of all other warranties, expressed or implied, including, without limitation, the warranties of merchantability and fitness for a particular purpose, and of all other obligations or liabilities on the part of the manufacturer. The manufacturer neither assumes nor authorizes any other person to assume for it any other liability in connection with the sale or use of any of the manufacturer’s products. Not withstanding any other provision herein or in any other document or communication. The manufacturer’s liability with respect to this agreement and products sold hereunder shall be limited to the aggregate purchase price for the goods sold by the manufacturer to the customer. There are no warranties which extend beyond the terms hereof. The manufacturer disclaims any liability hereunder or elsewhere in connection with the sale of this product, for indirect or consequential damages. The manufacturer reserves the right to make changes in equipment built and/or sold by it at any time without incurring any obligation to make the same or similar changes on equipment previously built and/or sold by them. The products listed above are manufactured in the United Kingdom by: Customer Service USA: Technical Service:

Customer Service: 1-800-852-9361 1-800-621-3739 www.gyrusacmi.com

Gyrus Medical Limited, Fortran Road, St Mellons, Cardiff CF3 0LT, UK.

TCRF and Somnoplasty are trademarks or registered trademarks of Gyrus Medical, Ltd., and/or its affiliated entities, in the U.S. and/or other countries

Gyrus ACMI Electrosurgical Generator (TCRFTM) USER MANUAL Gyrus ACMI Part No: 135015-FB

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The manufacturer warrants the products listed below to be free from defects in material and workmanship under normal use and service for the period(s) set forth below. The manufacturer’s obligation under this warranty is limited to the repair or replacement, at its sole option, of any product, or part thereof, which has been returned to it or its Distributor within the applicable time period shown below after delivery of the product to the original purchaser, and which examination discloses, to the manufacturer’s satisfaction, that the product is defective. This warranty does not apply to any product, or part thereof, which has been repaired or altered outside the manufacturer’s factory in a way so as, in the manufacturer’s judgment, to affect its stability or reliability, or which has been subjected to misuse, neglect or accident.

TABLE OF CONTENTS SECTION

PART

1B 1C

INTRODUCTION Overview of the G1 Temperature-Controlled Radio Frequency(TCRF)TM Electrosurgical Generator Indications for Use Contraindications for Use

1-1 1-1

2A 2B

PATIENT AND OPERATING ROOM SAFETY Warnings Precautions

2-1 2-3

3A 3B 3C

GENERAL INFORMATION Product Description System Components Accessories

3-1 3-1 3-1

4A 4B 4C 4D 4E

SETUP AND OPERATION Generator Indicators and Displays Settings Modes of Operation Settings Displays

4-1 4-2 – 4-3 4-4 4-4 – 4-6 4-7 – 4-17

5A 5B

BEFORE SURGERY Overview Steps for set up and operation

5-1 5-1 – 5-2

6A

DURING SURGERY Activation

6-1 – 6-2

7A 7B

AFTER SURGERY Cleaning the Generator Cleaning the footswitch

7-1 7-1

8A

OPERATING ROOM TROUBLESHOOTING Alert Messages

8-1 – 8-2

9A 9B

PERFORMANCE SPECIFICATIONS Product and System Specification Power Curve

9-1 - 9-2 9-2

10A 10B

EXPLANATION OF SYMBOLS Symbols and Icons Glossary of Terms

10-1 10-2

11A

PERIODIC EQUIPMENT SAFETY CHECKS Periodic Inspections

11-1

EMC TABLES

12-1

1 1A

3

4

5

6

7

8

9

10

11

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SECTION 1 1A

INTRODUCTION

OVERVIEW OF THE GYRUS ACMI G1 TEMPERATURE-CONTROLLED RADIO FREQUENCY (TCRF)TM ELECTROSURGICAL GENERATOR The Gyrus ACMI Electrosurgical Temperature-Controlled Radio Frequency (TCRF)TM Generator delivers a high-frequency alternating current through an electrode needle into surrounding tissue. Ionic agitation occurring in the tissue results in molecular vibration that produces heat. The heat is generated in the tissue, not in the electrode.

The first algorithm allows the user to adjust two parameters - target temperature and energy - prior to delivering radio frequency (RF) energy. During the procedure, the Generator then automatically adjusts the power to achieve and maintain the target temperature. Optimum coagulation volume is achieved when tissue temperature is maintained between 65°C and 85°C. Under the second algorithm, the user adjusts the target energy, prior to delivering RF energy. During the procedure the Generator automatically adjusts the power to follow a temperature profile optimized to deliver maximum coagulation volume over a treatment times of typically less than one minute. Through precise control of temperature and power, tissue temperature is able to approach 100°C without desiccation or charring. 1B.

INDICATIONS FOR USE The Gyrus ACMI Electrosurgical Temperature-Controlled Radio Frequency (TCRF)TM Generator with the Temperature Controlled Radio Frequency (Somnoplasty) Electrodes is indicated for coagulation of soft tissue including: The coagulation of enlarged tonsils in patients 13 years of age and older; the reduction of the incidence of airway obstructions, e.g., base of tongue, soft palate, etc., in patients suffering from UARS or OSAS; tissue coagulation in the inferior turbinates; and tissue coagulation in the uvula/soft palate which may reduce the severity of snoring in some individuals. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment and familiar with potential complications that may arise during or following Head and Neck surgery.

1C.

CONTRAINDICATIONS FOR USE There are no known absolute contraindications to the use of radio-frequency surgery. The use of the Generator is contraindicated when, in the judgment of the physician, electrosurgical procedures would be contrary to the best interests of the patient. The use of the system is also contraindicated for patients with active implants. Temperature-Controlled Radio Frequency (TCRF) may be contraindicated in patients with a compromised immune system.

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As the temperature in the tissue increases, tissue coagulation occurs leading to cell necrosis. The tissue temperature and lesion size are affected by the radio frequency power level, the length of the active portion of the needle, and the duration of the power application. The Generator operates offering a choice of one of two automated algorithms.

SECTION 2 2A.

PATIENT AND OPERATING ROOM SAFETY

WARNINGS Please read this manual and follow its instructions carefully, including those provided with the coagulating electrodes, prior to use. The words WARNING, CAUTION and NOTE convey special meanings and are used to indicate information that should be carefully reviewed to ensure the safe and effective operation of the Generator.

•

Please read all indication-specific Professional Use Guides and Instructions for Use accompanying Gyrus ACMI tissue coagulating electrodes and reusable cables prior to use. Periodically inspect the electrodes and cables for possible damage to the insulation and discard any cables in a damaged condition.

•

Hazardous electrical output. This equipment is intended for use only by qualified medical personnel trained in the use of electrosurgery.

•

Electrical shock hazard. The Generator is not user-serviceable. Do not attempt to remove the cover of the Generator or perform service on its parts. Refer servicing to qualified Gyrus ACMI personnel only.

•

Failure of high frequency surgical equipment may result in an unintended increase in output power.

•

Burns to the operator’s hands are possible if the needle of the active electrode comes into contact with a metal instrument or surface.

•

Explosion Hazard: Do not use in the presence of flammable anesthetics.

•

The use of flammable anesthetics or oxidizing gasses such as nitrous oxide (N2O) and oxygen should be avoided if a surgical procedure is carried out in the region of the thorax or head, unless these agents are sucked away.

•

Non-flammable agents should be used for disinfection and cleaning wherever possible.

•

Some materials, for example cotton, wool and gauze, when saturated with oxygen may be ignited by sparks produced in normal use of electrosurgical equipment.

•

The sparking and heating associated with electrosurgery can provide an ignition source. Observe fire precautions at all times.

•

The electrode needle must be used fully extended.

•

Activation of an electrosurgical device when not in contact with target tissue or in a position to deliver energy to the target may cause capacitive coupling.

•

The electrode tips should NOT be removed during RF On mode as RF is being delivered constantly. Superficial skin burns could occur.

•

No equipment is to be connected to the rear panel digital interface during surgical use. This interface is provided for use by trained service engineers only.

•

No other electrosurgery system should be used on a patient simultaneously with the Gyrus ACMI G1 TCRFTM Generator.

•

In the unlikely event of the generator not behaving as documented, temporarily disconnect the power from the unit to reset its operation.

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SECTION 2

PATIENT AND OPERATING ROOM SAFETY

EMC CLASSIFICATION The G1 System has been manufactured and tested to the following requirements: Group 2 Class A as per IEC60601-1-2 (2001) EMC PRECAUTIONS

EMC WARNINGS •

The generator should not be used adjacent to or stacked with other electrical equipment. If adjacent or stacked use is necessary both the generator and other equipment should be observed to verify normal operation in the configuration in which it will be used.

•

The EMC classification of the G1 system (class A) is suitable for use on dedicated supply systems not connected to the public mains network, such as hospitals. NOTE: Although class A limits have been derived for industrial and commercial establishments, administrations may allow, with whatever additional measures necessary, the installation and use of class A ISM equipment in a domestic establishment or establishment connected directly to domestic electricity power supplies.

•

Portable and mobile RF communications equipment can affect medical electrical equipment.

•

The use of accessories and cables other than those for which the system was designed can significantly degrade emissions and immunity performance.

•

Keep the accessory cables away from cables from other electrical equipment. Electrical currents may be induced in the other equipment causing unintended effects.

•

Do not use a monopolar generator/accessories simultaneously with the G1 generator. Activation of a monopolar generator/accessories may cause interference with the G1 generator resulting in user message changes on the display. Before proceeding with surgery, confirm proper power settings are displayed on the generator. Ensure the appropriate output setting is enabled for the desired surgical outcome.

•

Provide as much separation as possible between the generator and other electronic equipment (such as monitors). When activating the generator, unintended electromagnetic coupling may cause interference with the other equipment.

•

Should any unintentional effects appear upon other equipment when using the generator, repositioning the generator, the connecting leads or other equipment may alleviate the problem. It may also help to use different mains supply sockets for any affected equipment

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Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information in this document.

SECTION 2 2B.

PATIENT AND OPERATING ROOM SAFETY

PRECAUTIONS Allow for adequate air circulation around the generator to prevent internal heat buildup. Do not install the Generator near sources of direct heat or in a place subject to direct sunlight, excessive dust or humidity, mechanical vibration or shock.

•

Impedance values do not ensure that the needle tip is correctly positioned within the tissue being treated.

•

The entire area of the dispersive (neutral) electrode should be reliably attached to the patient’s body and as close to the operating field as possible. Follow all of the manufacturer’s Instructions for Use for the proper placement of the dispersive electrode.

•

Apparent low output or failure of the Generator to function correctly at normal operating settings may indicate faulty application of the dispersive (neutral) electrode or poor contact in its connections. In this case, the application of the dispersive electrode and its connections should be checked.

•

The patient should not come into contact with metal parts which are earthed or which have an appreciable capacitance to earth (e.g. operating table supports, etc.).

•

Skin-to-skin contact (e.g. between the arms and body of the patient) should be avoided, for example by insertion of dry gauze.

•

When high frequency electrosurgical equipment and physiological monitoring equipment are used simultaneously on the same patient, any monitoring electrodes should be placed as far as possible from the surgical electrodes. Monitoring systems incorporating high frequency current-limiting devices are recommended.

•

The cable to the surgical electrode should be positioned in such a way that contact with the patient or other leads is avoided. Temporarily unused active electrodes should be stored so that they are isolated from the patient.

•

Do not perform electrosurgical procedures in the presence of flammable anesthetics or oxidizing or bio-intestinal gases. Use non-flammable agents for cleaning and disinfecting wherever possible. Flammable agents used for cleaning or disinfecting, or as solvents of adhesives, should be allowed to evaporate before the application of high frequency electrosurgery.

•

Do not touch the tip of the coagulating electrode and the dispersive electrode at the same time, especially when operating the Generator. Superficial skin burns could occur.

•

Simultaneous use of radio frequency mode with irrigation may alter the path of electrical energy away from the target tissue.

•

If the Generator fails to deliver RF energy, discontinue use and contact Gyrus ACMI Technical Support as detailed on the front of this manual.

•

The generator cannot be sterilized and therefore the generator must be placed outside the sterile field, and must not be touched by sterile users.

•

A suitable earthed, hospital grade, mains supply cable should be used to connect the generator to the mains electricity supply. The mains electricity supply should be a suitable wall socket. Multiple portable socket-outlets should not be used for connection of the equipment.

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•

GENERAL INFORMATION

SECTION 3 3A.

PRODUCT DESCRIPTION The Electrosurgical Temperature-Controlled Radio Frequency (TCRF)TM Generator is a dual channel electrosurgical Generator that produces low-power, monopolar RF energy at approximately 444 kHz. The Generator delivers up to 15 watts of power per channel (30 watts max total.). Features of the Generator include: a Footswitch for hands-free initiation and cessation of RF energy delivery; and

•

real-time displays for temperature, energy and impedance.

Internal and edge-of-lesion temperatures are measured during treatment by thermocouples located at the tip of the needle and at the end of the insulation, respectively. RF generation stops if the tip temperature exceeds 7°C above the user or generator set value, the insulation temperature exceeds 65°C, the impedance is below 35 ohms or above 500 ohms, or when pre-set total energy is reached. 3B

SYSTEM COMPONENTS 

Generator



Footswitch



User Manual CAUTION: Use of components or accessories not outlined in this manual could affect the safety of the Generator.

3C

ACCESSORIES See Gyrus ACMI’s Product Catalogue for other accessories available for use with the Generator, including: •

Models 1010, 1120, and 1200 Single-needle Coagulating Electrodes

•

Models 2220 and 2420 Dual-needle Coagulating Electrodes

•

RC-2 and RC-20 Reusable Cables

•

Return Electrode (ConMed Corp. P/N 400-2100 or Valley Lab P/N E7506)

•

Needle Sleeve bending tool (for use only with the Model 1010 Tissue Coagulating Electrode).

The electrodes must not be re-used. The electrode Instructions for Use should be consulted before using electrodes.

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•

SECTION 4 4A

SETUP AND OPERATION

GENERATOR INDICATORS AND DISPLAYS The Generator has four operating and one standby mode: Standby Mode – The Power LED blinks on the front of the generator to indicate standby condition.

2.

RF Off – The Generator is idle; no RF energy is delivered.

3.

Sensing – Discrete bursts of RF energy are delivered allowing the Generator to measure the impedance in the circuit. When paused, the Generator operates in this Mode.

4.

RF On – RF energy is delivered continuously

5.

Alert – where errors identified by the system are annunciated. TM

Gyrus ACMI G1 Temperature-Controlled Radio Frequency (TCRF) Generator

Electrosurgical

Figure 4-1 Generator and Components

Figure 4-2 Generator Front Control Panel

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1.

SECTION 4 4B

SETUP AND OPERATION

SETTINGS Keypad: Standby/On, Up, Down Arrows and Mode Button The keypad allows parameter increment or decrement and control of instrument set-up and standby to on.

The Standby/On button switches the Generator back and forth between the Standby and Operating modes. The green indicator will change from flashing to continuous when the equipment mode changes from Standby to RF Off by pressing the button. Pressing and holding the button again will switch the equipment to Standby mode.

Up/Down Arrows Depressing the up or down arrow when parameter change is permitted increases or decreases the parameter step-wise. Holding the button down will increase or decrease the value in preset steps Mode / Menu This button provides access to the setup menu if held down in RF Off and RF Sensing modes. If pressed when the system is paused during delivery of RF (see below) then it will stop the delivery of RF for that sequence and reset accumulated totals to zero. If the button is held down until the volume change option is displayed then the following options are available:   

Volume may be altered from 1 to 12 as required Press the Mode button again Display intensity can be set from 25% to 100% in 25% steps. Press the Mode button again Select whether to display impedance or insulation temperature during treatment.

Footswitch -Blue Pedal The footswitch blue pedal is used to administer RF energy, thus it can be used to progress from RF Off Mode to RF Sense, and from RF Sense to RF On. If pressed in RF On it will pause delivery, and if pressed again will resume delivery. To commence delivery of RF energy it should be pressed and then released. It is not necessary to hold it down to deliver energy. Footswitch - Mode Footswitch The footswitch Mode footswitch has three main functions: it allows the mode change from RF Sensing to RF Off; and in RF On mode it changes the display of Impedance to Insulation temperature and back again; at the end of RF energy delivery pressing the Mode footswitch returns the unit to RF Off condition.

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Standby / On

SETUP AND OPERATION

SECTION 4 Figure 4-3 Generator Back Panel View

7

6

1

3

5

2

1. 2.

3. 4.

5.

AC Power Connector Connector for the AC line power cable. Equipotential Connector The connection for the Potential Equalization Conductor terminates at this point. Power Switch Switch to turn the Generator on/off. Footswitch Connector The Footswitch is used to initiate the RF On Mode. Depressing it during RF delivery pauses the Generator; depressing it again resumes RF delivery. Fuse Compartment Location of line fuses.

6.

7.

RS232 Connector Used by qualified Gyrus ACMI technical personnel only. Do not connect any device to this port. Fuse Label Provides information on correct fuse to use for fuse replacement.

WARNING: Replace only with T-series 3.15A, 250V fuse certified to IEC 127 (5 x 20 mm fuse).

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4

SECTION 4 4C

SETUP AND OPERATION

MODES OF OPERATION The Generator has four operating modes: RF Off, Sensing, RF On, and Alert. Generator Modes

Sensing Mode: Parameter entry as described in RF Off remains accessible in this mode. Using RF bursts, temperature and impedance displays can assist in positioning the coagulating electrode. Press the footswitch Blue pedal to change to RF On Mode. RF On: Real-time displays for needle tip temperature and energy appear together with impedance or insulation temperature as selected are displayed on this screen during RF delivery. Depressing the footswitch Blue pedal during RF energy delivery pauses the process. Discrete RF energy bursts allow for impedance monitoring during the pause. Alert: Alert codes are displayed when the equipment detects abnormal operation. There are three levels of alert: 1 Minor warnings. 2 Operating fault detected 3 System error detected. 4D

SETTINGS RF Off Mode This mode is entered after the system is switched on the screen indicates “Data Entry”. In this mode the connection of an instrument is requested and recognized and the target temperature and target Joules to be delivered can then be set. It is not possible to progress past this screen without setting a non-zero value for Target Energy. In the RF Off Mode, the following parameters should be set prior to treatment: Electrode Target Tip Temperature Pressing the up/down arrows changes the target temperature between 65oC and 85oC with a resolution of 1oC. Rapid coagulation temperature control is selected if the up arrow is pressed at the upper limit of user temperature adjustment. Conversely pressing the down arrow whilst Rapid coagulation is selected returns to user determined tip temperature control. If the arrows are held down the temperature changes in 5oC increments. Releasing and re-pressing the key returns it to 1oC increments. For ease of configuration, it is recommended that that temperature control selection be made prior to setting the target energy level. The default temperature setting is 75oC. Target Energy (Joules) The target energy, in Joules, to be delivered over the permissible range during treatment is set in 25-Joule steps by pressing the up/down arrows. Under user determined temperature control, the range of adjustment is from 0 to 5000 Joules, but this is limited to between 50 and 300 Joules per RF channel if Rapid coagulation is selected. Due to the reduced time for thermal diffusion under Rapid coagulation temperature control, the target energy level set under the two temperature control algorithms are not equivalent, and target energy should be set with consideration of the type of temperature control selected.

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RF Off Mode: The user can select either user defined temperature control or a rapid coagulation, generator determined, temperature control. In either case target energy can be set to affect the volume of coagulated tissue. Press the footswitch Blue pedal or Mode button to change to the Sensing Mode.

SETUP AND OPERATION

SECTION 4

If the arrows are held down the energy changes in 100J increments. Releasing and repressing the key returns it to 25 Joule increments. Note: For dual channel electrodes the displayed reading is the total Joules for both channels.

Figure 4-4 RF Off Screen. Showing target temperature set to 75C and target Joules set to 2925J.

RF Off Tip 1 Tip 2 Target

26°C 26°C 75°C

Ins Ins

26°C 26°C 2925J

Sensing Mode Real-time values for the needle tip temperature and either insulation temperature or impedance are displayed on the Sensing screen to assist the user in positioning the coagulating electrode. The Generator delivers discrete bursts of RF energy in the Sensing Mode in order to measure impedance. Impedance values do not ensure that the needle tip is correctly positioned within the tissue being treated. RF On Mode Real-time displays for needle tip and insulation temperature or impedance, as selected, energy (Joules), and duration appear in this screen during RF delivery. A bar graph displays energy delivered. The user may adjust the selected parameters during RF delivery, if desired.

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Impedance / Insulation Temperature Selection If the Mode button is pressed and held for more than 3 seconds then the User Setup Menu can be accessed. The menu can be worked through by pressing the Mode button repeatedly until the required set up parameter is visible. When the Insulation temperature / Impedance set up menu is visible the required mode of operation can be selected. Pressing the Mode button again places the system back into the RF Off condition. In this mode the Insulation temperature will be displayed if selected, otherwise this area of the screen will remain blank, the Impedance will be only displayed in RF Sensing and On modes, if this option has been selected. Press the Blue foot-pedal once to progress to the RF Sensing condition.

SECTION 4

SETUP AND OPERATION

1. Return (Dispersive) Electrode Connector The return (dispersive) electrode provides a path for the RF current through the patient to the Generator. CAUTION: It is important to properly attach the return electrode to the patient (see Section 2 Warnings & Precautions ).

2. Coagulating Electrode Connector Gyrus ACMI coagulating electrodes are available for use with the Generator. Use the 9-pin coagulating electrode connector on the front panel to connect the coagulating electrodes to the Generator. The coagulating electrodes are for single use only. Do not attempt to sterilize and/or reuse them. 3. Power On Indicator The Power On Indicator blinks green in standby mode and continuous green after successful completion of the start-up self tests in ready, RF on and alert modes. 4. Fault Indicator The Fault Indicator light illuminates red when the Generator encounters an internal condition precluding operation. This may include a self-test failure. The Generator will not deliver power when the fault indicator light is on (see Section 8, Troubleshooting). 5. RF On Indication The screen will display “RF Sensing” when the Generator delivers RF energy in discrete bursts during the Sensing Mode. While delivering continuous RF power for treatment the screen will display “RF On” There will also be an audible bleep as every 50J is delivered on a single channel instrument and every 100J on a two-channel instrument. 6.

Active Socket Indication The green LED adjacent to the Temperature-Controlled Radio Frequency (TCRF)TM socket will light when an electrode is fitted and recognized.

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The return electrode is for single use only.

SETUP AND OPERATION

SECTION 4

4E

DISPLAYS Figure 4-5

If there is no hand-piece fitted when the unit is powered up the display prompts the user to Attach Cable and Instrument. Figure 4-6

2 Channel Instrument Detected

Once a hand-piece is fitted the display will indicate the type that has been attached (e.g. 1 Channel or 2 Channel.) It will then display the Data entry screen below. Figure 4-7

Data Target Temperature 80°C

Entry Target Energy OJ

The initial data entry screen starts with user determined temperature control. This allows the user to set the target temperature (C) and target energy (Joules).

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Attach Cable and Instrument

SETUP AND OPERATION

SECTION 4

Target temperature is the treatment tip temperature, and the Target Energy is the total number of Joules to be delivered during treatment by 1 or 2 channels dependant on the number of channels of the attached electrode NOTE: Target Joules must be set to more than 0Joules to proceed. If Rapid Lesion generation is to be used, this selection should be made prior to adjusting the target energy. If the left up arrow is pressed repeatedly, Rapid Lesion is selected.

Figure 4-8

Data Entry Auto Temperature Rapid Lesion

Target Energy 100J

This allows the user to set the target energy (Joules). Treatment tip temperature is set to be controlled by the generator to maximize lesion generation. Figure 4-9

****** Volume

change

05 

V

Holding the Mode button down for 5 seconds will enter into user options, for volume control, display intensity, or to select Insulation temperature or Impedance display during treatment. Figure 4-10

100% Display intensity

Gyrus ACMI Electrosurgical Generator (TCRFTM) USER MANUAL Gyrus ACMI Part No: 135015-FB



V

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The Data entry screen below for Rapid Lesion will be displayed.

SETUP AND OPERATION

SECTION 4

Volume control and display intensity use bar graphs to indicate where in the current settings range the control is set. These settings may be changed by pressing the right hand side up and down arrows. The Display insulation Temp or Impedance during treatment is toggled by pressing either of the right hand side, up or down arrows. Figure 4-11

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Display Insulation Temp or Impedance During Treatment? INSULATION TEMP

Figure 4-12

Display Insulation Temp or Impedance During Treatment? IMPEDANCE

Figure 4-13

RF Off Tip1 Tip2 Target

22°C 22°C 80°C

Gyrus ACMI Electrosurgical Generator (TCRFTM) USER MANUAL Gyrus ACMI Part No: 135015-FB

300J

Page 4-9

SETUP AND OPERATION

SECTION 4

Figure 4-14

RF Off Tip1 22°C Tip2 22°C Rapid Lesion

100J

On the bottom row of the screen, on the left, either the currently selected target temperature is displayed or an indication for Rapid Lesion Mode. On the bottom row on the right, the currently selected Joules are shown. This target energy may be adjusted by pressing the relevant up/down keys below. Once beyond the RF Off mode screen, transition between user determined temperature control and Rapid Lesion Mode is no longer possible, until after the end of RF treatment. NOTE: No RF is being delivered at this stage. It is therefore safe to remove or insert the hand piece tips into the patient’s tissue. Figure 4-15

RF Off Tip1 Tip2 Target

22°C 22°C 80°C

Ins 22°C Ins 22°C 300J

Figure 4-16

RF Sensing On 38°C Tip1 Tip2 22°C Target 80°C

Imp 50 Imp > 500 300J

Gyrus ACMI Electrosurgical Generator (TCRFTM) USER MANUAL Gyrus ACMI Part No: 135015-FB

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OSTE UK CONTROLLED COPY DO NOT PHOTOCOPY

Once the data entry screen has been left the RF Off mode screen is shown. This displays the current tip temperatures and if insulation temperature is set to display during treatment these are also shown on the right after Ins for each channel (see below).

SETUP AND OPERATION

SECTION 4

Figure 4- 17

RF Sensing On Auto Temperature Rapid Lesion

Imp1 50 Imp2 > 500 100J

User determined control: Temperature Display Under user determined temperature control, the value is displayed in °C (Celsius) for needle tip temperature. Tip temperature for a single-channel handpiece is displayed on the second row of the display. If a two-channel handpiece is used, tip temperature for the second electrode is displayed on third row of the display. If RF energy delivery is paused, real-time temperature values continue to display. Insulation Temperature Display (not shown) The value is displayed in °C (Celsius) for needle insulation temperature if selected. Insulation temperature for a single-channel handpiece is displayed on the first row (1). If a two-channel handpiece is used, temperature for the second electrode is displayed on the second row (2). This will only be displayed if selected from the Setup Menu. Real-Time Impedance Display Real-time impedance values display in ohms () when in Sensing or RF On Mode. CAUTION: Impedance values indicate whether there is a complete electrical circuit. They do not ensure that the needle tip is correctly positioned within the tissue being treated. If RF energy is paused, impedance values continue to monitor. Impedance for a singlechannel handpiece is displayed on the first row (1). If a two-channel handpiece is used, impedance for the second electrode is displayed in the second row (2). This will only be displayed if selected from the Setup Menu. The two displays below show the Insulation Temperature being displayed on the right of the screen after Ins. User determined temperature control has been chosen in the first example screen below, and the currently selected target temperature is shown. In the second example screen, Rapid Lesion Mode is determined by the generator and there is no user adjustment. The currently selected Joules are shown on the right. Values may be adjusted by pressing the relevant up/down keys below.

Gyrus ACMI Electrosurgical Generator (TCRFTM) USER MANUAL Gyrus ACMI Part No: 135015-FB

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OSTE UK CONTROLLED COPY DO NOT PHOTOCOPY

During RF sensing mode the impedance between each tip and the return pad is being measured; if it is selected for display during the procedure it will be displayed on the right after Imp for each channel. Otherwise the insulation temperature is displayed on the right after Ins (see below). The current Tip temperature is displayed for each channel after TIP1 or TIP2. (see section 6A for further information)