Argon Gas Delivery II User Guide March 2006

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 user’s guide for the Valleylab Force Argon II System only. For complete instructions for use regarding the Force Electrosurgical Generator, refer to the appropriate instruction manual. Caution Federal (USA) law restricts this device to sale by or on the order of a physician.

Patent information: The Force Argon II System and handsets are covered by the following U.S. Patent Numbers: 5,088,997; 5,217,457; 5,244,462; 5,908,402; 6,139,519; 6,558,383. Trademark acknowledgments: Force FX™, Force EZ™, Force Argon™, Force GSU™, SurgiStat™, REM™, EDGE™, AccuVac™, PolyHesive™, and Instant Response™ are trademarks of Valleylab. Freon® is a registered trademark of E.I. DuPont de Nemours & Co. Equipment covered in this manual: Valleylab Force Argon II Unit 240 VAC nominal, 50-60 Hz Valleylab Part Number: 1002362 Effective Date: March 2006 Manufactured by: Valleylab a division of Tyco Healthcare Group LP Boulder, Colorado 80301-3299 USA For information call: 1-303-530-2300 European Representative: Tyco Healthcare UK Ltd. Gosport,PO13 0AS, UK

Made in USA Printed in USA ©2006 Valleylab All rights reserved.

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Force Argon II-8 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 which may result in product damage. Important Indicates an operating tip or maintenance suggestion.

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Force Argon II-8 User’s Guide

Conventions Used in this Guide ... iii

Chapter 1. Introducing the Force Argon II System The Advantages of Argon-Enhanced Electrosurgery ...1-2 Valleylab Force Argon II System Components...1-3 Force Argon II Unit Components...1-3 Components Ordered Separately ...1-3 Valleylab Force Argon II System Features ...1-4 Overpressure System ...1-4 RF Input Receptacle for the Valleylab Argon Accessory ...1-4 Patient and Operating Room Safety ...1-5 General ...1-6 Fire/Explosion...1-7 Fire Hazard with Oxygen Circuit Connections ...1-8 Inadvertent Radio Frequency (RF) Burns ...1-8 Electrosurgical Smoke ...1-8 Laparoscopic Procedures...1-9 Gas...1-10 Ensure Proper Connections ...1-10 Active Accessories ...1-10 Servicing ...1-10 Contraindications ...1-11 Before Surgery...1-12 Active Accessories ...1-12 Patient Return Electrodes ...1-12 Generator ...1-12 Electrodes ...1-14 During Surgery...1-14 Electrodes ...1-14 Argon-Enhanced Electrosurgery ...1-15 Use of Argon-Enhanced Coagulation on the Digestive Tract ...1-16 Contact with Metal Objects ...1-16 Generator and Gas Flow Settings...1-16 Return Electrodes ...1-17 Active Accessories ...1-17

Chapter 2. Controls, Indicators, and Receptacles Force Argon II Front Panel ...2-2 Overpressure System ...2-3 System Purge Control ...2-3 Gas Flow Controls ...2-3 Gas Tank Indicators and Controls ...2-4 Gas Lines and Receptacles ...2-4 Force Argon II Rear Panel Descriptions ...2-5

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Chapter 3. Before Surgery Setting Up the Force Argon II Unit for Surgery ... 3-2 Typical Power and Gas Flow Settings for Electrosurgery ... 3-12

Chapter 4. During Surgery Gas Control with the E2520 ArgonPlus Handset ... 4-2 Activating the E2520 ArgonPlus Handset ... 4-2 Extend or Retract the Electrode ... 4-3 Using the Laparoscopic Electrodes ... 4-4 Gas Control with the Valleylab Argon Accessory ... 4-5 Selecting and Switching Gas Tanks ... 4-5 Low or Empty Gas Tanks ... 4-5 Handset Tubing Obstruction ... 4-5 Peritoneal Pressure Tubing Obstruction ... 4-6 Overpressure Setting Exceeded... 4-6

Chapter 5. After Surgery Disconnecting Accessories from the Force Argon II Unit ... 5-2 Cleaning the Force Argon II Unit ... 5-3

Chapter 6. Operating Room Troubleshooting Alarm Conditions ... 6-2 Functional Problems ... 6-3

Chapter 7. Maintenance and Repair Responsibility of the Manufacturer ... 7-2 Maintenance ... 7-2 Replacing the Argon Gas Tanks... 7-2 Adjusting the Feet of the Force Argon II Unit ... 7-4 Returning the Force Argon II Unit for Service ... 7-5 Obtaining a Return Authorization Number ... 7-5 Returning the Force Argon II Unit ... 7-6 Disposing of the Force Argon II Unit ... 7-6 Service Centers ... 7-7

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Force Argon II-8 User’s Guide

Chapter 8. Technical Specifications Standard Conditions of Measurement...8-2 Operating Parameters...8-2 Storage and Shipping ...8-2 Input Power Source ...8-2 Low Frequency Leakage (50-60 Hz) ...8-2 Gas Flow Ranges ...8-2 Audio Volume ...8-2 Approximate Weight ...8-2 Size ...8-3 Power Cord Specification ...8-3 Gas Tanks...8-3 Standards and IEC Classifications ...8-4 Type CF Equipment (IEC 60601-1) /Defibrillator Proof ...8-4 Liquid Spillage (IEC 60601-2-2 Clause 44.3) ...8-4 EMC Compatibility...8-5 Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2) ...8-5

Chapter 9. Warranty

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Force Argon II-8 User’s Guide

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Chapter

1

Introducing the Force Argon II System

This user’s guide will instruct you in the use of the Valleylab Force Argon II System. In this chapter, you’ll become familiar with the features of the system, its capabilities, and the precautions associated with its safe use. This guide and the equipment it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed. Additional technical information is available in the Force Argon II System Service Manual.

Force Argon II-8 User’s Guide

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The Advantages of Argon-Enhanced Electrosurgery The Valleylab Force Argon II System is designed to provide a controlled flow of argon (an inert, nonreactive gas) over the active electrode of an electrosurgical accessory which is powered by a Valleylab Force series electrosurgical generator. A variety of handsets provide argon-enhanced electrosurgery as well as standard electrosurgery. Valleylab electrosurgical generators, patient return electrodes, and active accessories are designed to work as a system. Valleylab offers a selection of patient return electrodes and electrosurgical instruments that are fully compatible with this generator. When considering other manufacturer’s patient return electrodes and/or active accessories, customers should seek detailed user instructions and warning information from the manufacturer. When using a Valleylab Force series electrosurgical generator in conjunction with the Force Argon II Unit, the surgeon can expect: •

Improved visibility of the target tissue

•

A more finely directed coagulation effect

•

Enhanced control at higher power settings

Argon-enhanced coag permits the coagulation of certain tissue in a more controlled manner than with standard electrosurgical coagulation. In argon-enhanced coag, activating the handset creates an argon gas plasma between the electrode and the tissue. The presence of inert gas at the surgical site inhibits combustion with other gases (e.g., oxygen, nitrogen, etc.) and pushes residual smoke, water vapor, or fluids away from the surgical site, thereby improving visibility. The Force Argon II Unit has an overpressure system that continuously measures peritoneal cavity pressure in real-time. This system operates when the unit is in the low flow range for argon gas (0.5 - 4 LPM), i.e. the gas flow range for laparoscopic procedures. Use the overpressure system in conjunction with a carbon dioxide insufflator monitor. Warning The overpressure system does not take the place of an insufflator monitoring system and does not control the peritoneal cavity pressure. The overpressure system operates independently of an insufflator. The manufacturer’s preset overpressure alarm system allows argon gas to continue to flow through an activated handset during an overpressure alarm condition. Under these circumstances, the potential for a gas embolism may increase as the peritoneal cavity pressure rises.

Important Using argon-shrouded cut at higher power levels may increase arching from the electrode to adjacent tissue.

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Force Argon II-8 User’s Guide

Valleylab Force Argon II System Components

The Force Argon II Unit offers you the ability to use the Valleylab Argon Accessory. Simply attach the RF jumper cable coming from the electrosurgical generator to the RF Input receptacle on the front panel.

Valleylab Force Argon II System Components The Valleylab Force Argon II System includes components received with the Force Argon II Unit and components ordered separately.

Force Argon II Unit Components •

Electronics Module

•

RF Jumper Cable

•

ESU Interface Cable

•

E0502-12 Active Adapter

•

Argon Gas Tank Regulator Assembly/Tank 1

•

Power Cords (2)

•

User’s Guide, Service Manual, Reference Card

Components Ordered Separately

Force Argon II-8 User’s Guide

•

Valleylab Force 30, Force 40, Force 300, or Force FX series Electrosurgical Generator

•

E2520H ArgonPlus Handset

•

Argon Accessory

•

E2520PT Peritoneal Pressure Tubing

•

REM Patient Return Electrode

•

GR200 Argon Gas Tank Regulator Assembly/Tank 2

•

GT202 Argon Gas Tank Holders (2)

•

Argon Gas Tanks

•

ESU Footswitch E6008 or E6008B

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Introducing the Force Argon II System

The overpressure system senses when the peritoneal cavity pressure meets or exceeds the user selectable setpoint (between 5 and 30 mm Hg). Before the peritoneal cavity pressure reaches the setpoint, the Overpressure indicator on the front panel illuminates, and an intermittent alarm sounds. When the peritoneal cavity pressure meets or exceeds the setpoint, the Overpressure indicator on the front panel remains illuminated, and a continuous alarm sounds.

Valleylab Force Argon II System Features

Valleylab Force Argon II System Features Overpressure System The system measures the peritoneal cavity pressure during laparoscopic procedures when the peritoneal pressure tubing is connected between the Force Argon II Unit and a cannula. When you select the low gas flow range (0.5 - 4 LPM [standard liters per minute]) on the front panel, the overpressure system automatically selects 5 mm Hg as the default for the alarm setting. By turning the Overpressure control knob, you can replace the default setting with your chosen setting (between 5 and 30 mmHg). The overpressure system senses when the peritoneal cavity pressure meets or exceeds the setpoint. As the peritoneal cavity pressure approaches the setpoint, the Overpressure indicator on the front panel illuminates, and an intermittent alarm sounds. When the peritoneal cavity pressure meets or exceeds the setpoint, the Overpressure indicator on the front panel remains illuminated, and a continuous alarm sounds. The overpressure system may be turned off by pressing the Overpressure On/Off switch on the Force Argon II front panel. Argon gas continues to flow through the activated handset when an overpressure alarm condition exists. However, the Force Argon II Unit may be adjusted through the RS-232 serial port on the rear panel to stop argon gas delivery when the peritoneal cavity pressure meets or exceeds the selected setpoint. Contact your Valleylab representative for further information.

RF Input Receptacle for the Valleylab Argon Accessory If you want to use the Valleylab Argon Accessory for surgery, connect the RF jumper cable from the Force Argon II Unit to the electrosurgical generator. Front Panel Arrangement - The front panel is arranged in functional sections for ease of set up and use: •

Overpressure system (operates only in low gas flow range)

•

System purge control

•

Gas flow controls

•

Gas tank indicators and controls

•

Gas line, RF input, peritoneal pressure tubing, and handset receptacles

REM Safety - The Force Argon II Unit is designed for use with a Valleylab Force electrosurgical generator with the REM Contact Quality Monitor. The REM system is designed to minimize the risk of burns at the return electrode site due to a reduction in patient contact area during monopolar electrosurgery. Two Gas Flow Ranges - You may select a low gas flow range (0.5 - 4 LPM) or a standard gas flow range (0.5 - 12 LPM) to use argon-enhanced electrosurgery in a wide range of laparoscopic and open surgical applications. Handset Tubing Obstruction Alarm - When the handset tubing is occluded or kinked, an alarm sounds, the Obstruction indicator illuminates, and the Gas Flow indicator flashes. Until you remove the obstruction, you can use standard electrosurgery but not argon-enhanced coag or argon-shrouded cut.

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Force Argon II-8 User’s Guide

Patient and Operating Room Safety

Automatic Gas Tank Switching - When one tank becomes low, the unit automatically selects the alternate tank, if available, with no interruption of gas flow to the handset. Low Tank Pressure Alarm - An alarm sounds when the gas tank pressure becomes low in all available tanks.

Patient and Operating Room Safety The safe and effective use of electrosurgery depends to a large degree upon factors solely under the control of the operator. There is no substitute for a properly trained and vigilant operating room staff. It is important that the operating instructions supplied with this or any electrosurgical equipment be read, understood, and followed. Electrosurgery has been used safely in numerous procedures. Before starting any surgical procedure, the surgeon should be trained in the particular technique and surgical procedure to be performed, should be familiar with the medical literature related to the procedure and potential complications, and should be familiar with the risks versus the benefits of using electrosurgery in the procedure. All warnings and precautions regarding the use of electrosurgery apply to the Force Argon II System. Use the Force Argon II Unit only with a Valleylab Force 30, Force 40, Force 300, or Force FX series electrosurgical generator.

Force Argon II-8 User’s Guide

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Introducing the Force Argon II System

Peritoneal Pressure Tubing Obstruction Alarm - When the peritoneal pressure tubing is occluded or kinked, an alarm sounds, the Obstruction indicator illuminates, and the Overpressure indicator flashes. Until you remove the obstruction, you can use standard electrosurgery but not argon-enhanced coag or argon-shrouded cut.

Patient and Operating Room Safety

General Warning Accidental and unintended burn injury has occurred during procedures in small surgical fields and on small appendages. Catastrophic results have been reported in the context of neonatal and pediatric circumcisions.1, 2 In those cases of confirmed thermal injury during neonatal and pediatric circumcisions, the mechanism of injury appears to have been associated with contact between a metal clamp (such as a Gomco clamp or a Kocher clamp) in the surgical field and the active electrode, which greatly increased current flow. (See “Contact with Metal Objects” later in this chapter for further information on the dangers of contact with metal instruments.) It has also been reported that properly trained physicians use electrosurgery safely in the performance of circumcisions, and that pediatric urologists use electrosurgery with surgical procedures performed on the genitals of male neonates. In performing such procedures, it is reported that many physicians use the ESU in coagulation mode to achieve hemostasis of bleeders, however “buzzing” hemostats clamped to bleeders may increase the risk of thermal injury.

1. The American National Standard for Electrosurgical Devices (ANSI/AAMI HF 18-1993) provides: “Electrosurgery should not be used to perform circumcisions.” 2. Information on the safe use and thermal hazards associated with the use of high frequency electricity (electrosurgical machines) in health care facilities appear in NFPA 99, Annex 2, reference in the JCAHO Accreditation Manual for Hospitals.

Warning Use electrosurgery with caution in the presence of internal or external pacemakers. Interference produced with the use of electrosurgical devices can cause devices such as 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 electrosurgical appliances is planned in patients with cardiac pacemakers. Valleylab recommends against the use of laparoscopic surgery on pregnant patients. Do not use electrosurgical equipment unless properly trained to use it in the specific procedure being undertaken. Use by physicians without such training has resulted in serious, unintended patient injury, including bowel perforation and unintended, irreversible tissue necrosis. Hazardous Electrical Output-This equipment is for use only by trained, licensed physicians.

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Force Argon II-8 User’s Guide

Patient and Operating Room Safety

Always use the lowest output setting necessary to achieve the desired surgical effect. In order to lessen the possibility of unintended burn injury, use the active electrode only for the minimum time necessary. Pediatric applications and/or procedures performed on small anatomic structures may require reduced power settings. The higher the current flow and the longer the current is applied, the greater the possibility of unintended thermal damage to tissue, especially during use on small appendages. This equipment, when used in conjunction with an electrosurgical generator, has an output which is capable of producing a physiological effect. Read the instructions, cautions, and warnings provided with electrosurgical accessories before using. Specific instructions for electrosurgical accessories are not included in this manual.

Fire/Explosion Warning Explosion Hazard-Do not use in the presence of flammable anesthetics. Fire/Explosion Hazard-The following substances will contribute to increased fire and explosion hazards in the operating room: • flammable substances (such as alcohol based skin prepping agents and tinctures) • naturally occurring flammable gases which may accumulate in body cavities such as the bowel • oxygen enriched atmospheres • oxidizing agents (such as nitrous oxide [N2O] atmospheres) The sparking and heating associated with electrosurgery can provide an ignition source. Observe fire precautions at all times. When using electrosurgery in the same room with any of these substances or gases, prevent their accumulation or pooling under surgical drapes, or within the area where electrosurgery is performed.

Force Argon II-8 User’s Guide

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Introducing the Force Argon II System

Caution

Patient and Operating Room Safety

Fire Hazard with Oxygen Circuit Connections Warning Fire/Explosion Hazard-Verify that all oxygen circuit connections are leak free before and during the use of electrosurgery. Verify that endotracheal tubes are leak free, and that the cuff is properly sealed to prevent oxygen leaks.

Inadvertent Radio Frequency (RF) Burns Warning Electrodes and probes used with monitoring, stimulation, and imaging devices (or similar equipment) can provide a path for high frequency current even if the electrodes or probes are isolated at 50-60 Hz, insulated, and/or battery operated. To reduce the risk of an inadvertent electrosurgical burn at the electrode or probe site, place the electrode/probe as far away as possible from the electrosurgical site and/or patient return electrode. Protective impedances (resistors or RF inductors) installed in the monitoring leads may reduce the risk of such burns. Consult the hospital biomedical engineer for further information. Do not use needles as monitoring electrodes during electrosurgical procedures. Inadvertent electrosurgical burns may result. In some circumstances, potential exists for alternate site burns at points of skin contact (e.g., between the arm and the side of the body). This occurs when electrosurgical current seeks a path to the patient return electrode which includes the skin to skin contact point. Current passing through small skin to skin contact points is concentrated and may cause a burn. This is true for grounded, ground referenced, and isolated generators. To reduce the potential for alternate site burns, do one or more of the following: • Avoid skin to skin contact points, such as fingers touching leg, when positioning the patient. • Place two to three inches of dry gauze to ensure that contact does not occur. • Position the patient return electrode to provide a direct current route between the surgical site and the return electrode which avoids skin to skin contact areas. • Place patient return electrodes according to the manufacturer's instructions. Potential for alternate site burns increases if the return electrode is compromised. Valleylab recommends the use of REM patient return electrodes and Valleylab generators with the REM system.

Electrosurgical Smoke Caution Studies have shown that smoke generated during electrosurgical procedures can be potentially harmful to surgical personnel. These studies recommend using surgical masks and adequately ventilating the smoke by using a surgical smoke evacuator or other means.

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Force Argon II-8 User’s Guide

Patient and Operating Room Safety

Warning Do not exceed insufflation pressures normally recommended for laparoscopic procedures. The addition of argon gas during the procedure increases the risk of excess intra-abdominal pressure. Continuously monitor insufflation pressures. To minimize this risk, do not exceed an argon gas flow of four liters per minute. For laparoscopic procedures be alert to these potential hazards: • Laparoscopic surgery may result in gas embolism due to insufflation of gas into the abdomen. • The electrode tip may remain hot enough to cause burns after the electrosurgical current is deactivated. • Inadvertent activation or movement of the activated electrode outside of the field of vision may result in injury to the patient. • Localized burns to the patient or physician may result from electrical currents carried through conductive objects (such as cannulas or scopes). Electrical current may be generated in conductive objects by direct contact with the active electrode, or by the active accessory (electrode or cable) being in close proximity to the conductive object. • Do not use hybrid trocars that are comprised of both metal and plastic components. For the operative channel, use all metal or all plastic systems. At no time should electrical energy pass through hybrid systems. Capacitive coupling of RF current may cause unintended burns. • When using laparoscopic instrumentation with metal cannulas, the potential exists for abdominal wall burns to occur due to direct electrode contact with or capacitive coupling of RF current. This is most likely to occur in instances where the electrosurgical generator is activated for extended periods at high power levels and induced high current levels in the cannula. • Ensure that the insulation of disposable and reusable laparoscopic instrumentation is intact and uncompromised. Compromised insulation may lead to inadvertent metal to metal sparking and neuromuscular stimulation and/ or inadvertent sparking to adjacent tissue. • Do not activate electrodes while in contact with other instruments as unintended tissue injury may occur. • Do not activate the generator in an open circuit condition. Activate the generator only when the active electrode is near or in direct contact with the target tissue to lessen the possibility of creating unintended burns. • Use the lowest power setting that achieves the desired surgical effect and use a low voltage waveform (cut mode) to lessen the potential for the creation of capacitive currents. • Carefully insert and withdraw active electrodes from cannulas to avoid possible damage to the devices and/or injury to the patient.

Force Argon II-8 User’s Guide

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Introducing the Force Argon II System

Laparoscopic Procedures

Patient and Operating Room Safety

Gas Warning Use only high purity grade (99.998% pure, or better) argon gas. Patient safety may be compromised by using low purity gas. Studies have indicated that argon gas in the blood stream is expelled from the lungs with each breath. Small infants and patients with COPD or other respiratory conditions may not clear argon from their blood stream as quickly. The regulator coupling in this unit is compatible with many common gas tanks (e.g., Freon®, helium, krypton, neon, nitrogen, and xenon). Only connect argon gas to the Force Argon II System. Using other gases may affect gas flow, create phosgene or other harmful gases, or create an explosion hazard. Ensure that argon gas tanks and fittings used with the Force Argon II System have been pressure tested, certified, and filled according to applicable standards and local codes. Do not overpressurize tanks.

Caution Improperly secured gas tanks and/or improper connection of high pressure gas lines may result in injury.

Ensure Proper Connections Caution Examine all accessories and connections to the electrosurgical generator before using. Ensure that the accessories function as intended. Improper connection may result in arcs and sparks, accessory malfunction, or unintended surgical effects.

Active Accessories Warning Do not wrap the accessory cords or patient return electrode cords around metal objects. This may induce currents that could lead to shocks, fires, or injury to the patient or surgical personnel.

Servicing Warning Electrical Shock Hazard-Do not remove covers. Refer to authorized personnel for service.

Notice Refer to the service manual for maintenance recommendations and function and output power verification procedures.

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Force Argon II-8 User’s Guide

Patient and Operating Room Safety

Right to Left Cardiac Shunting Valleylab recommends against using the Force Argon II System on patients with right to left cardiac shunting due to the increased risk of arterial gas emboli. Atrial Septal Defect Valleylab recommends against using the Force Argon II System on patients with atrial septal defect due to an increased risk of arterial gas emboli. Small Patients Valleylab recommends against using the Force Argon II System for laparoscopic procedures on patients weighing less than 30 kilograms, due to the smaller volume of the peritoneal cavity in such patients and the concomitantly greater rate at which the influx of gas into the cavity could cause its pressure to rise to potentially unsafe levels.

Force Argon II-8 User’s Guide

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Introducing the Force Argon II System

Contraindications

Before Surgery

Before Surgery Active Accessories Warning Connect the handset to the Force Argon II front panel only when the electrosurgical generator is off or in the standby mode. Connect accessories to the proper receptacle. Improper connection of accessories may result in inadvertent accessory activation or other potentially hazardous conditions. Follow the directions provided with electrosurgical accessories for instructions on proper connection and use. Electric Shock Hazard-Do not connect wet accessories to the generator. Electric Shock Hazard-Ensure that all accessories and adapters are correctly connected and that no metal is exposed.

Caution Read the instructions, warnings, and cautions provided with the active accessories before using. Accessories labeled “disposable” are single use only. Do not reuse or resterilize.

Patient Return Electrodes Valleylab recommends the use of REM dual section patient return electrodes to maximize patient safety. Warning The safe use of monopolar electrosurgery requires proper placement of the patient return electrode. To avoid radio frequency burns beneath the patient return electrode, follow all directions on the product package for proper return electrode placement and use. Do not cut a patient return electrode to reduce size. Patient burns due to high current density may result. Do not apply a patient return electrode for a bipolar only procedure. Otherwise the electrosurgical effect may not be limited to the tissue between the bipolar electrodes. Using a conventional patient return electrode without the REM safety feature will not activate the Valleylab REM Contact Quality Monitoring System.

Generator Warning Electric Shock Hazard-Connect the generator power cord to a properly grounded receptacle. Do not use power plug adapters.

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Force Argon II-8 User’s Guide