Cool-tip RF Service Manual May 2004

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 servicing the 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 Part Number Effective Date

945 103 094 May 2004

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. Trademark acknowledgements

Cool-tip™ is a trademark of Valleylab. All trade names referenced are the trademarks, registered trademarks, or products of their respective manufacturers. European representative

Tyco Healthcare UK Ltd. Gosport, PO13 0AS, UK Device is compliant with the European Communities Council Directive 93/42/EEC, Medical Device Directive. Valleylab a division of Tyco Healthcare Group LP 5920 Longbow Drive Boulder, CO 80301 USA Tyco Healthcare UK Ltd. Gosport, PO13 0AS, UK Internet address

http://www.valleylab.com

Printed in USA ©2004 Valleylab All rights reserved.

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Cool-tip RF Service Manual

Warranty The Seller warrants to the original purchaser of this product that the product substantially conforms to its written specifications current at the date of delivery of such product and shall perform for a period of one year from such date of delivery substantially in accordance with those specifications. The obligations of the Seller and any affiliate of the Seller under this warranty shall be limited to repair or replacement of a nonconforming product, at the option of the Seller. The above warranty is contingent upon use of the product in accordance with its intended use and pursuant to operating instructions contained in the specifications. This warranty does not cover products that have been modified without the Seller’s prior approval or which have been subject to unusual physical or electrical stress. EXCEPT AS STATED ABOVE, THERE ARE NO OTHER WARRANTIES. THE SELLER EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, WRITTEN OR ORAL, WITH RESPECT TO PRODUCTS, INCLUDING WITHOUT LIMITATION, IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NONINFRINGEMENT.

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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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Cool-tip RF Service Manual

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

Chapter 1. Service Personnel Safety Safety Information ... 1-2 Warnings, Cautions, and Notices ... 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 ... 1-5 Cool-tip RF Electrodes ... 1-5 Procedural Warnings & Cautions ... 1-6 Cleaning and Disinfection ... 1-6

Chapter 2. Introduction Intended Use ... 2-2 Contraindications ... 2-2 General Description... 2-2 System Setup ... 2-2 RF Generator ... 2-2 System Pump ... 2-3 Preparation of Cooling Fluid ... 2-3 Placement of Grounding Pads ... 2-3 RF Electrode and Tubing Setup ... 2-4 System Connection Diagram ... 2-5

Chapter 3. Controls, Indicators, and Receptacles Explanation of Symbols ... 3-2 Cool-tip Generator Front Panel ... 3-4 Cool-tip Generator Rear Panel ... 3-5 System Pump Description ... 3-6

Chapter 4. Technical Specifications Device Classification ... 4-2 Electrical Safety and EMC ... 4-2 Cool-tip Generator ... 4-2 System Pump ... 4-3 Cool-tip Generator Specifications ... 4-3

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v

Serial Ports ... 4-6 Generator Output Power Characterization ... 4-8 System Pump Specifications ... 4-9

Chapter 5. Principals of Operation Features ... 5-2 Impedance ... 5-2 RF Current ... 5-2 RF Watts ... 5-2 Temperature ... 5-2 Status Display Messages ... 5-3 Control Features... 5-7 Timer... 5-7 Impedance Control Mode ... 5-7 Manual Control Mode ... 5-8 Output Connections ... 5-8 Patient connections ... 5-8 Patient Output ... 5-9

Chapter 6. Setup, Tests, and Adjustments Testing the CC-1 Coagulator ... 6-2 Tools and Equipment Needed ... 6-2 Initial Inspection ... 6-2 Input Voltage Configuration ... 6-2 Power Up Test ... 6-3 Knob Settings ... 6-3 Temperature TC/TM Check ... 6-3 Impedance Mode Check... 6-4 Audio Check ... 6-5 Footswitch Check ... 6-5 Final Inspection ... 6-5 Manual Mode Test ... 6-5

Chapter 7. Troubleshooting Cool-tip Generator ... 7-2 System Pump ... 7-3

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Chapter 8. Repair Policy and Procedures Maintenance and Service... 8-2 Returning the Generator for Service ... 8-2 Step 1 - Obtain a Return Authorization Number ... 8-2 Step 2 - Clean the Generator ... 8-3 Step 3 - Ship the Generator ... 8-3 Service Centers ... 8-4

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NOTES

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Cool-tip RF Service Manual

Chapter

1

Service Personnel Safety

1

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

Safety is stressed in the use and servicing of electrosurgical equipment. This section presents the following: • Safety information • Warnings, cautions, and notices Refer to the Conventions section in the preface for further information on warnings, cautions, and notices.

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Safety Information

Safety Information The safe and effective servicing of coagulation equipment depends to a large degree on factors solely under the control of the service person. There is no substitute for a properly trained and vigilant service staff.

Warnings, Cautions, and Notices Before servicing the generator, it is important that you read, understand, and follow the instructions supplied with it and with any other equipment used to install, test, adjust, or repair the generator.

Cool-tip RF System Caution Electric Shock Hazard There are no user serviceable parts inside the Cool-tip RF generator. To avoid electric shock, return the unit to Valleylab for servicing. Warning Hazardous Electrical Output This equipment is intended for use by qualified personnel only. Do not use within 4 m (15 ft) of a cardiac pacemaker. This equipment has an output that is capable of causing a physiological effect. Risk of Burns and Fire Do not use near conductive materials, such as metal bed parts. 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 Cool-tip 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 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. Warning The risk of igniting flammable gases or other materials is inherent in electrosurgery and cannot be eliminated by device design. Precautions must be taken to restrict flammable materials and substances from the electrosurgical site. The use of flammable anesthetics, nitrous oxide, and oxygen should be avoided if a surgical procedure is performed in the thorax or the head, unless these agents are evacuated or anesthetic-proof equipment is used. Flammable agents used for cleaning, disinfecting, or as solvents of adhesives should be allowed to evaporate before the application of RF surgery. There is a risk of pooling of flammable solutions under the patient and in body cavities. Any fluid pooled in these areas should be removed before the equipment is used. Attention should be called to the danger of ignition of endogenous gases. Some materials such as cotton, wool, and gauze, when saturated with oxygen may be ignited by sparks produced during normal use of the device.

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Service Personnel Safety

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 system. Consult the Cool-tip RF electrode Instructions for Use.

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. Warning If it is suspected that RF energy is being delivered to the patient after pressing the OFF button or releasing the footswitch, 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 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 support. 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 coagulation 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.

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Cool-tip RF Service Manual

General Safety Information

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 grounding pad Instructions for Use as provided in the Cooltip RF electrode kit. These Instructions for Use 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. 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. Follow Instructions for Use provided 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. 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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Service Personnel Safety

Grounding Pads

Procedural Warnings & Cautions

Procedural Warnings & Cautions Warning 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 system and electrodes.

Caution Safe and effective coagulation 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.

Cleaning and Disinfection The Cool-tip RF system reusable components may be cleaned with mild cleaning solutions, such as 70% isopropyl alcohol. Care should be taken to keep moisture out of the connectors. Store both units and accessories in a clean, dry, and non-corrosive atmosphere. The generator, pump, and accessories are designed to withstand all normally encountered environmental conditions (see “RF Generator Specifications” and “Pump Specifications”). The Cool-tip RF electrode kits are for SINGLE USE ONLY. Do not clean or re-sterilize products prior to use. Do not attempt to reuse Cool-tip RF electrodes and grounding pads. Caution Do not sterilize the Cool-tip RF system generator or pump. Sterilization will destroy the unit’s electronic components.

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Cool-tip RF Service Manual

Chapter

2

Introduction

1

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

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2-1

Intended Use

Intended Use The Cool-tip RF system is intended for coagulation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.

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.

General Description The Cool-tip RF system consists of an RF generator, peristaltic pump, cables, and accessories. The Cool-tip RF generator is a microprocessorbased generator capable of supplying up to 200 watts of radiofrequency 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 Cooltip 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 RF Generator 1. Note voltage requirement of unit. The unit is configured with the

appropriate nominal input voltage. To change the input voltage setting, perform the following: a. Locate the fuse drawer on the back of the unit. This drawer holds a

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

indicator arrow. c. 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.

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System Setup

Caution Failure to correctly set a voltage may permanently damage the unit. If the voltage selection is changed to the 100 V or 120 V setting, the fuses must be 5x20 mm, 4 A, 250 V, Slo-Blo fuses (part number CON-FU-0051). If the voltage selection is changed to the 220 V or 240 V setting, the fuses must be 5x20 mm, 2 A, 250 V, Slo-Blo fuses (part number CON-FU-0050). 2. Plug power cord into the rear of the RF generator. 3. Plug power cord into a hospital grade AC receptacle of the proper

voltage. 4. Rotate the handle downward by simultaneously pressing the buttons

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 • 1000-3000 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 by 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.

Placement of Grounding Pads Place grounding pads as directed in the grounding pad instructions for use.

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Introduction

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 Setup

RF Electrode and Tubing Setup Use the following steps to attach the tubing sets and electrode: Note: Be sure both the system generator and pump are plugged in. 1. Suspend the IV bag on IV pole or place IV bottle in basin. Verify that

air bubbles rise to the top. 2. Open protective cover to access roller clamp. 3. Place inflow tubing into roller clamp. Distance between clamp and

clear tubing should be about 10-15 cm. Distance approximately 10-15cm

To Electrode

From Sterile Water Direction of Flow

Note: Confirm proper orientation of tubing to ensure correct flow direction of chilled water. Note direction of arrows on pump. 4. Close cover. Pump will not operate if cover is not completely closed. 5. Attach inflow tubing to IV bag by inserting spike into bag (roller clamp

can be temporarily closed prior to procedure). 6. Attach outflow tubing set to the outlet irrigation port of the electrode.

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

tubing attachments to 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.

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System Connection Diagram

System Connection Diagram

DGP-HP Grounding Pads (2X) for Single Electrode (4X) for Cluster Electrode

Cool-tip RF System Generator C123 Connector

Sterile Water <20˚ C in IV Bag for Electrode Cooling

Cool-tip Electrode

Outflow Container

System Pump

Inflow Tubing (Tan) (PE-IV)

Outflow Connector (Clear Tube) Inflow Connector (Blue Tube)

Cool-tip RF Service Manual

Introduction

Outflow Tubing (Clear) (PE-TO)

DGP-HP-EXT Extension Cable

C123 Adapter Cable

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NOTES

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Cool-tip RF Service Manual