Cool-tip Users Guide Jan 2017

This manual and the equipment it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed. It is intended as a guide for using the Valleylab Cool-tip™ RF ablation system only. Caution Federal (USA) law restricts this device to sale by or on the order of a physician. Equipment covered in this manual

Cool-tip™ RF ablation system Valleylab Part Number 1004817 Effective Date January 2007 Notices

No part of this document may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means–electronic, mechanical, photocopying, recording, or otherwise–without written consent of Valleylab. Additional copies of this document can be ordered from Valleylab. Patent Information

Protected by U.S. patent number 6,506,189 Trademark acknowledgements

Valleylab™, ForceTriad™, Force FX™, Force EZ™, Force Argon™, LigaSure™, LigaSmart™, Smart™, Cool-Tip™, REM™, RFG-3C™, OptiMumm™, SurgiStat™, EDGE™, AccuVac™, PolyHesive™, and Instant Response™ are trademarks of Valleylab. European representative

Tyco Healthcare UK Ltd. Gosport, PO13 0AS, UK Printed in USA ©2006 Valleylab All rights reserved. Device is compliant with the European Communities Council Directive 93/42/EEC, Medical Device Directive. Manufactured by

Valleylab, a division of Tyco Healthcare Group LP Boulder, Colorado 80301-3299 USA For information call

1-303-530-2300 Internet address

http://www.valleylab.com

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Cool-tip RF User’s Guide

Warranty Valleylab, a division of Tyco Healthcare Group LP, warrants each product manufactured by it to be free from defects in material and workmanship under normal use and service for the period(s) set forth below. Valleylab’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 Valleylab’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 Valleylab’s factory in a way so as, in Valleylab’s judgment, to affect its stability or reliability, or which has been subjected to misuse, neglect, or accident. The warranty periods for Valleylab products are as follows: ForceTriad™ Energy Platform

One year from date of shipment

Electrosurgical Generators

One year from date of shipment

RFG-3C™ Plus Lesion Generator

One year from date of shipment

LigaSure™ Vessel Sealing System

One year from date of shipment

LigaSure™ Reusable Instruments

One year from date of shipment

Mounting Fixtures (all models)

One year from date of shipment

Footswitches (all models)

One year from date of shipment

Force Argon™ Units

One year from date of shipment

OptiMumm™ Smoke Evacuator

Two years from date of shipment

LigaSure™ Sterile Single Use Items

Sterility only as stated on packaging

Sterile Single Use Items

Sterility only as stated on packaging

Patient Return Electrodes

Shelf life only as stated on packaging

This warranty is in lieu of all other warranties, express 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 Valleylab. Valleylab neither assumes nor authorizes any other person to assume for it any other liability in connection with the sale or use of any of Valleylab’s products. Notwithstanding any other provision herein or in any other document or communication, Valleylab’s liability with respect to this agreement and products sold hereunder shall be limited to the aggregate purchase price for the goods sold by Valleylab to the customer. There are no warranties which extend beyond the terms hereof. Valleylab disclaims any liability hereunder or elsewhere in connection with the sale of this product, for indirect or consequential damages.

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This warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the State of Colorado, USA. The sole forum for resolving disputes arising under or relating in any way to this warranty is the District Court of the County of Boulder, State of Colorado, USA. Valleylab, its dealers, and representatives reserve the right to make changes in equipment built and/or sold by them at any time without incurring any obligation to make the same or similar changes on equipment previously built and/or sold by them.

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Cool-tip RF User’s Guide

Conventions Used in this Guide Warning Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Caution Indicates a hazardous situation which, if not avoided, may result in minor or moderate injury. Notice Indicates a hazard that may result in product damage. Important Indicates an operating tip or maintenance suggestion.

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Warranty ... iii Conventions Used in this Guide ... v

Chapter 1. System Overview Electrical Warnings & Precautions ... 1-2 Cool-tip RF System ... 1-2 System Pump ... 1-3 General Safety Information ... 1-3 Cool-tip RF System ... 1-4 Grounding Pads ... 1-4 Cool-tip RF Electrodes ... 1-5 Procedural Warnings & Cautions ... 1-6 Intended Use ... 1-6 Contraindications ... 1-6 System Description ... 1-7 System Setup ... 1-7 RF Generator ... 1-7 System Pump ... 1-8 Preparation of Cooling Fluid ... 1-8 Placement of Grounding Pads ... 1-9 Removal of Grounding Pads ... 1-10 RF Electrode and Tubing Setup... 1-10 System Connection Diagram ... 1-13

Chapter 2. RF Generator Front Panel Controls... 2-2 Rear Panel Description ... 2-3 Display Features ... 2-4 Impedance ... 2-4 RF Current ... 2-4 RF Watts ... 2-4 Temperature ... 2-4 Status Display Messages ... 2-5 Testing Procedures... 2-8 Manual Mode Test ... 2-8 Control Features ... 2-8 Timer ... 2-8 Impedance Control Mode ... 2-9 Manual Control Mode ... 2-10 Output Connections ... 2-10 Patient connections ... 2-10 Patient Output ... 2-11 Serial Ports ... 2-11 Troubleshooting... 2-13

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RF Generator Symbols...2-14 System Pump Symbols ...2-16 RF Generator Specifications ...2-17 ...2-18

Generator Output Power Characterization ...2-18

Chapter 3. System Pump Features and Description ...3-2 Troubleshooting ...3-3 Pump Specifications ...3-3

Chapter 4. RF Electrodes Description ...4-2

Chapter 5. Ablation Procedures Determining Resectability ...5-2 Lesion Sizes and Ablation Times ...5-3 Multiple Ablations ...5-3 Determining the Completeness of the Ablation ...5-4 Hepatic Tumor Ablation Procedure Recommendations ...5-5 Summary of Ablation of Hepatic Metastases with Cool-tip RFA ...5-6 Summary of Ablation of Hepatocellular Carcinoma with Cool-tip RFA...5-7 Referenced Articles: Hepatic Tumor Ablation...5-8 Osteoid Osteoma Tumor Ablation Recommendations ...5-9 Recommendations ...5-9 Determinations of Clinical Outcome ...5-9

Chapter 6. Technical Reference Device Classification...6-2 Electrical Safety and EMC ...6-3 Generator ...6-3 System Pump ...6-3 EMC for Cool-tip Generator and System Pump ...6-4 Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2) ...6-4 Guidance and Manufacturer's Declaration - Electromagnetic Emissions...6-4 Guidance and Manufacturer's Declaration - Electromagnetic Immunity ...6-5 Guidance and Manufacturer's Declaration - Electromagnetic Immunity ...6-6 Recommended Separation Distances Between Portable and Mobile RF Communication Equipment and the Cool-tip RF Generator ...6-7 Cleaning and Disinfecting ...6-8 Maintenance and Service ...6-8

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Chapter 7. Cool-tip Switching Controller Intended Use ... 7-1 Warnings and Cautions ... 7-2 Cool-tip RF Electrodes ... 7-3 System Instructions ... 7-4 System Setup ... 7-5 Preparing the Patient for the Procedure ... 7-6 Starting the Procedure... 7-9 Interrupting the Ablation Cycle ... 7-10 Cauterizing the Needle Track ... 7-10 Cleaning and Disinfecting ... 7-11 Troubleshooting... 7-11 Symbols ... 7-12 Front Panel Symbols ... 7-12 Rear Panel Symbols ... 7-13 Technical Specifications ... 7-14 Electrical Supply ... 7-14 Impedance Monitor ... 7-14 Timer ... 7-14 Average Power Monitor ... 7-14 Current Monitor ... 7-14 Temperature Monitor ... 7-14 Operating Environment ... 7-15 Storage and Transport Conditions... 7-15 Warm-up Time ... 7-15 Device Classification ... 7-15 Electrical Safety and EMC ... 7-16 Cool-tip Switching Controller ... 7-16 EMC for Cool-tip Switching Controller ... 7-16 Guidance and Manufacturer's Declaration - Electromagnetic Emissions ... 7-17 Guidance and Manufacturer's Declaration - Electromagnetic Immunity ... 7-17 Guidance and Manufacturer's Declaration - Electromagnetic Immunity ... 7-18 Recommended Separation Distances Between Portable and Mobile RF Communication Equipment and the Switching Controller ... 7-19 Status Messages... 7-20 Maintenance and Service ... 7-21 Switching Controller Placement and Spacing ... 7-21

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Chapter

1

System Overview

Caution Read all warnings, cautions, and instructions provided with this generator before use. Read the instructions, warnings, and cautions provided with RF accessories before use. Specific instructions are not included in this manual.

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Electrical Warnings & Precautions

Electrical Warnings & Precautions Cool-tip RF System Safe and effective ablation is dependent not only on equipment design, but also on factors under the control of the operator. Do not attempt to operate the generator and/or the pump prior to completely reading and understanding the directions for use. Please provide this manual to all personnel who will be operating or maintaining this system. Caution Electric Shock Hazard There are no user serviceable parts in the Cool-tip RF generator. To avoid electric shock, return the unit to Valleylab for servicing. Warning Use RF energy with caution in the presence of internal or external pacemakers. Interference produced by the use of RF devices can cause a pacemaker to enter an asynchronous mode or can block the pacemaker effect entirely. Consult the pacemaker manufacturer or hospital Cardiology Department for further information when use of RF appliances is planned in patients with cardiac pacemakers. If the patient has an implantable cardioverter defibrillator (ICD), contact the ICD manufacturer for instructions before performing an RF procedure. Activation of RF energy may cause multiple activations of ICDs. Danger: Explosion Hazard Do not use RF ablation in the presence of flammable anesthetics. Fire Hazard Heating associated with RF can be an ignition source. Keep gauze and sponges wet. Keep RF electrodes away from flammable materials and O2 enriched environments. Avoid the accumulation of naturally occurring flammable gases that may accumulate in body cavities such as the bowel. Prevent pooling of flammable fluids and the accumulation of flammable or oxidizing gases or vapors under surgical drapes or near the surgical site. Equipotential Ground Reliable grounding can only be achieved when the equipment is plugged into a receptacle marked “Hospital Grade.” Any interruption of the Protective Earth conductor will result in a potential shock hazard, which could cause injury to patient or operator.

Caution If the generator is used to deliver ≥50 W of RF output at sourcing loads of <100 Ω, the generator should be allowed sufficient time to cool between coagulations. A duty cycle of 30% should be used, with a maximum ON time of twenty (20) minutes.

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General Safety Information

Warning Electric Shock Hazard If the pump becomes wet, either from a leaking tube or liquid being sprayed on it, remove the electrical cord from the main outlet before proceeding to handle the pump. Electric Shock Hazard There are no user serviceable parts inside the system pump. To avoid electric shock, return the pump to Valleylab for servicing. This equipment has an output that is capable of causing a physiological effect. This pump is not explosion proof and must not be used in an explosive atmosphere.

General Safety Information The Cool-tip RF generator is a radiofrequency generator designed to produce local tissue heating at the tip of an electrode by radiofrequency current. The Cooltip RF system has been designed to comply with the requirements and standards of the international electrical safety codes. Special isolation transformers are imposed between power lines and internal Cool-tip RF generator circuitry, resulting in very low leakage current. The Cool-tip RF generator meets EN 60601-1 and EN 60601-2-2 and is designated Class 1 Type BF equipment. It is designed to be patient connected. The patient applied part is isolated from earth at high frequencies, and has been designed for continuous commercial service (CCS) operation with intermittent loading.

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System Overview

System Pump

General Safety Information

Cool-tip RF System Warning Valleylab requires the use of Cool-tip RF electrodes when using the Cool-tip RF ablation system. Consult the Cool-tip RF electrode instructions. If it is suspected that RF energy is being delivered to the patient after pressing the OFF button, immediately turn the main POWER switch to the Off (O) position and disconnect the electrode from the generator. Do not use the generator. Call Valleylab for service.

Caution When installing the pump tubing, be sure to use proper fittings and retaining clamps to avoid disconnection during use. Always use Valleylab inflow and outflow tubing sets and change tubing with every patient use. Apparent low power output or failure of the equipment to function correctly at normal settings may indicate faulty application of the grounding pad or failure of an electrical lead. Do not increase power before checking for obvious defects or misapplication. Effective contact between patient and grounding pad must be verified whenever the patient is repositioned after initial application of the grounding pad. Electromagnetic interference (EMI) produced by the generator or pump may adversely affect performance of other equipment during normal operation. If this occurs, increase distance between devices and cables. Plug devices into separate branch circuit outlets. Call Valleylab for assistance. Electrodes and probes for monitoring, stimulating, and imaging devices can provide paths for high frequency current even if battery powered, insulated, or isolated at line frequency. The risk of burns can be reduced, but not eliminated, by placing these electrodes or probes as far away from the ablation site and the grounding pads as possible. Protective impedance incorporated into the monitoring leads may further reduce the risk of burns and permit continuous monitoring during energy delivery. Do not use needles as monitoring electrodes during such procedures.

Grounding Pads Warning The use and proper placement of the grounding pads is a key element in the safe and effective use of the generator, particularly in prevention of padsite burns. Read and follow the instructions that are provided in the Cool-tip RF electrode kit. These instructions describe the preparation, placement, surveillance, removal, and use of all grounding pads. Use of Valleylab DGP-HP grounding pads that meet or exceed ANSI/AAMI requirements (HF18) is recommended.

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General Safety Information

Use two grounding pads when using the single Cool-tip RF electrode or four grounding pads when using the cluster Cool-tip RF electrode. This disperses and returns RF current over a larger area and minimizes heating effects at the pads. In all applications, care should be taken to maximize the surface area of the grounding pad. Place the pads each an equal distance from the treatment area. This helps avoid high current densities and resultant burns in adjacent tissue. Consult the instructions that came with the grounding pad. While coagulating, attention should be given to the grounding pads for signs of excess heating. Avoid skin-to-skin contact to prevent accidental burns. Valleylab recommends placing gauze pads at probable skin-to-skin contact sites.

Cool-tip RF Electrodes Warning Always inspect insulated electrodes and cables for chips or cracks before each use. If an electrode or cable has cracked or scraped insulation, RF current will flow out of these cracks, reducing the current concentration at the tip, and potentially cause burns at unintended sites. Do not proceed in a temperature-monitored procedure if the generator does not read body temperature with the pump off. Temperature will drop to the approximate temperature of the cooling fluid once the pump is activated. Tissue temperatures cannot be measured during treatment when the pump is on. To get consistent results when using the pump in the Impedance Control mode, increase the power at a slow and steady rate, so as to prevent temperature overshoots.

Caution Reusable cables and accessories should be function-tested and safety-tested periodically. Note: Always have additional accessories available in case a problem arises with one during a procedure. Note: Always record all parameters at regular intervals and at key times for a given technique.

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System Overview

Warning

Procedural Warnings & Cautions

Procedural Warnings & Cautions Warning Evaluation of tumors for proximity to critical structures is imperative prior to device placement. Avoid unintended injury to non-target tissue such as organs, vascular structures, and nerve structures by ensuring at least 1 cm between the device and structures not intended for ablation. Proximity to nerve structures is particularly critical. Standard biopsy technique is recommended for placement of the Cool-tip RF electrode. Follow-up imaging is recommended to assess the extent of tissue destruction. It is recommended that physicians avail themselves of preclinical training, a review of pertinent literature, and other appropriate education before attempting to use the Cool-tip RF ablation system and electrodes.

Caution Safe and effective ablation is dependent not only upon equipment design, but also on factors under the control of the operator. Do not attempt to operate the generator and/or pump prior to completely reading and understanding the directions for use. Please provide this manual to all personnel who will be operating or maintaining this system.

Intended Use The Valleylab Cool-tip RF ablation system (generator and accessories) is intended for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver tumors and osteoid osteoma tumors within bone.

Contraindications The Cool-tip RF system is contraindicated for use in patients with Implantable Pacemakers and Automatic Implantable Cardioverter/Defibrillators (AICDs), as they may be adversely affected by radiofrequency (RF) current.

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System Description

The Cool-tip RF ablation system consists of an RF generator, peristaltic pump, cables, and accessories. The Cool-tip RF generator is a microprocessor-based generator capable of supplying up to 200 watts of radio frequency power. The unit continuously monitors impedance, current, power, and temperature. The system pump uses rotating rollers that squeeze the tubing and push cooled fluid through the Cool-tip RF electrode. The Cool-tip RF electrodes can be used in percutaneous, laparoscopic, and intraoperative surgical procedures. The Cool-tip RF electrodes are available in single-electrode and cluster-electrode configurations. All electrodes are provided in kits containing grounding pads and inflow and outflow tubing sets. The cluster electrode kit includes an introducer to ease placement of the electrode.

System Setup Caution This unit was equipped from the factory with either a 110VAC hospital grade NEMA 5-15 power cord or a 220VAC CEE7/7 power cord. Should the AC power cord need to be replaced to match another plug configuration, the replacement plug/cable/receptacle configuration must meet or exceed the following specifications: 100-120VAC Cable - SJT18/3, IEC color code, maximum length 8 feet (2.5 meters) Plug - minimum 10A 125VAC Unit receptacle - IEC female, minimum 10A 125VAC 220-240VAC Cable - H05VVF3G1.0 VDE, maximum length 8 feet (2.5 meters) Plug - minimum 6A 250VAC Unit receptacle - IEC female, minimum 6A 250VAC

RF Generator Changing the input voltage setting 1. Note voltage requirement of unit. Note: The unit is configured with the appropriate nominal input voltage. 2. Locate the fuse drawer on the back of the unit. This drawer holds a voltage-

selector insert and two fuses. 3. To open the fuse drawer, lift up on the lower tab marked by the indicator

arrow.

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System Overview

System Description

System Setup

4. Remove voltage selector insert and reinsert with the proper line voltage

indicated for your institution. The window on the fuse drawer will display the voltage selection of the unit. Notice Failure to correctly set a voltage may permanently damage the unit. If the voltage selection is changed to the 100 V, 120 V, 220 V, or 240 V setting, the fuses must be 5x20 mm, 4 A, 250 V, Slo-Blo fuses.

RF generator setup 1. Plug power cord into the rear of the RF generator. 2. Plug power cord into a hospital grade AC receptacle of the proper voltage. 3. Rotate the handle downward by simultaneously pressing the buttons on both

sides of the unit. The handle locks into a number of different positions, allowing it to be used as an adjustable tilt stand or as a carrying handle.

System Pump 1. Plug the power cord into the rear of the pump. There is no need to adjust the

voltage of pump. 2. Plug the power cord into a hospital grade AC receptacle.

Preparation of Cooling Fluid Items needed: •

Container (3000 ml minimum) for fluid outflow

•

1000ml -3000 ml IV bag or bottle containing sterile water, chilled in refrigerator

1. Place the sterile water in a refrigerator 24 hours prior to the procedure to

ensure adequate cooling. 2. Remove sterile water from refrigerator immediately prior to the procedure to

prevent premature warming of the water. Note: Two liters of sterile water should be sufficient for one 12 minute application. The pump uses approximately 100 ml/min (1.2 liters/12 min treatment). A 3 liter bag can be used to provide sufficient fluid for up to two treatments. 3. Once the sterile water is fully circulated through the electrode and the

electrode is connected to the system, the temperature of the fluid will be displayed on the generator. The fluid temperature will typically be less than 20° C. If the temperature of the sterile water exceeds 25° C, the IV bag or bottle should be placed in a basin containing ice in order to lower the water temperature.

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System Setup

System Overview

Placement of Grounding Pads 1. Remove the clear plastic backing from the grounding pads.

2. Lightly touch each pad surface to verify adequate gel moisture. 3. Position the pads on the front and back of each of the patient’s thighs so the

longest edge of each pad is facing the torso. 4. Position the pads at an equal distance from the treatment area.

Two (2) pad configuration for Single Electrode Kit:

Four (4) pad configuration for Cluster Electrode Kit:

5. Apply the pads by laying one edge on the skin and smoothly pressing across

the pad until it is fully in contact with the skin. 6. Apply finger pressure on the adhesive borders and massage the entire pad area

to ensure proper contact. 7. Uncoil the cords and connect the pads to the extension cable

(DGP-HP-EXT). 8. Connect the extension cable to the generator.

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System Setup

Removal of Grounding Pads 1. At the end of the procedure, turn off the Cool-tip generator and disconnect the

pads. 2. To avoid skin trauma when removing the grounding pads, peel the pads off

slowly with one hand while supporting the underlying tissue with the other hand.

RF Electrode and Tubing Setup Note: Be sure both the generator and system pump are plugged in. 1. Suspend the sterile water IV bag on an IV pole or place the sterile water IV

bottle in basin. Verify that air bubbles rise to the top. 2. Open the protective cover on the system pump to access roller clamp.

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System Setup

3. Place the inflow tubing into the roller clamp. The distance between the clamp Note: Confirm proper orientation of tubing to ensure correct flow direction of chilled water. Note direction of arrows on pump. Distance approximately 10 cm -15 cm

To Electrode

From Sterile Water Direction of Flow

4. Close cover. The system pump will not operate if the cover is not completely

closed.

5. Attach the inflow tubing to sterile water IV bag by inserting the spike into bag

(roller clamp can be temporarily closed prior to procedure).

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System Overview

and the clear tubing should be about 10 cm -15 cm.

System Setup

6. Attach the outflow tubing set to the outlet irrigation port of the electrode.

Connect the free end to an outflow container. 7. Open the roller clamp on the inflow tubing. 8. See the System Connection Diagram on the next page for instructions on

tubing attachments to the electrode. Warning The Cool-tip RF electrode and tubing sets are sterile, single-use items. Do not resterilize or reuse. After the system is completely set up, do not proceed if the generator does not read body temperature before you begin delivering RF energy. Temperature will drop to approximately the temperature of the cooling fluid once the pump is activated. Tissue temperatures cannot be measured during treatment when the pump is activated.

Caution You must replace the tubing sets with each patient use. Remove tubing after each Cool-tip RF electrode procedure to minimize risks and to prevent contamination.

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