AR-9600 O.P.E.S. Electrosurgical Generator Users Guide Rev 5

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 O.P.E.S. Electrosurgical Generator only. Additional technical information is available in the O.P.E.S. Electrosurgical Generator Service Guide.

Equipment Covered in this Manual O.P.E.S. Electrosurgical Generator: Reference No.: AR-9600 Manufactured for Arthrex, Inc. by Bovie Medical Corporation, St. Petersburg, Florida, 33710-2902, USA.

For Information Contact Arthrex • 1370 Creekside Blvd. • Naples, FL 34108-1945 • USA U.S. Phone 1-800-934-4404 • Fax 239-643-6218 • International Phone +239-643-5553 www.arthrex.com Arthrex GmbH • Liebigstrasse 13, D-85757, Karlsfeld/München • Germany Phone 49 8131 59570 • Fax 49 8131 5957631 Arthrex S.A.S • 5 Avenue Pierre et Marie Curie, 559260 Lezennes• France Phone 33 3 20057272 • Fax 33 3 20057270 Arthrex Ltd. • Beehive Works/Milton Street, Sheffield, South Yorkshire S3 7 WL • England Phone 44 114 276 7788 • Fax 44 114 276 7744 Arthrex GesmbH • Triesterstrasse 10/1, 2351 Wiener Neudorf • Austria Phone 43 2236 893350-0 • Fax 43 2236 893350-10 Arthrex BvbA • Brederodestraat 184, B-2018 Antwerpen • Belgium Phone 32 3 2169199 • Fax 32 3 2162059 EC Representative: Peter J. Smith Medical Products Marketing 18 Yeates Close Thame OX9 3AR UK

Made in USA Printed in USA MC-55-065-001 Rev. 5 AR9600 UG ©2005 Arthrex, Inc. All rights reserved. Contents of this publication may not be reproduced without the written permission of Arthrex, Inc.

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Prior to use in a surgical procedure, carefully unpack and inspect the components for any sign of damage, which may have occurred during shipping. If shipping damage is suspected, notify Arthrex or any authorized Arthrex distributor immediately. Any such damage could compromise patient safety. If transport or first installation damage is not reported within 7 days of receiving the product, the warranty could be rendered void. We also refer to our general terms of business.

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 an operating tip, a maintenance suggestion, or a hazard that may result in product damage.

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TABLE OF CONTENTS Equipment Covered in this Manual...ii For Information Contact ...ii Conventions Used in this Guide ...iii Introducing the Arthrex O.P.E.S. Electrosurgical Generator...1-1 Key Features...1-2 Components and Accessories...1-3 Safety ...1-4 Controls, Indicators, and Receptacles...2-1 Front Panel...2-2 Symbols on the Front Panel...2-3 Preset Controls...2-4 Cut and Blend Controls ...2-5 Coag Controls ...2-6 Bipolar Controls...2-7 Indicators...2-8 Power Switch and Receptacles...2-9 Rear Panel ...2-10 Symbols on the Rear Panel ...2-10 Getting Started ...3-1 Initial Inspection ...3-2 Installation ...3-2 Function Checks...3-2 Setting Up the Unit ...3-2 Checking the Return Electrode Alarm...3-2 Confirming Modes ...3-3 Checking Bipolar Mode (with bipolar footswitch) ...3-3 Checking Monopolar Mode (with monopolar footswitch) ...3-3 Checking Monopolar Mode (with handswitch) ...3-3 Performance Checks...3-3 Using the Arthrex O.P.E.S. Electrosurgical Generator ...4-1 Inspecting the Generator and Accessories ...4-2 Setup Safety...4-2 Setting Up ...4-3 Preparing for Monopolar Surgery...4-4 Applying the Return Electrode ...4-4 Connecting Accessories ...4-4 Preparing for Bipolar Surgery...4-5 Memory Presets and Factory Settings...4-5 Memory...4-5 Memory Function Overview...4-5 Setting Your Presets...4-6 Factory Presets ...4-6 Blend Controls...4-7 Memory Feature (Last Used Preset)...4-8 Activating the Unit ...4-9 Activation Safety...4-9

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Maintaining the Arthrex O.P.E.S. Electrosurgical Generator ...5-1 Cleaning ...5-2 Periodic Inspection...5-2 Fuse Replacement ...5-2 Troubleshooting...6-1 Error Codes and Audio Tones ...6-2 Repair Policy and Procedures ...7-1 Responsibility of the Manufacturer...7-2 Returning the Generator for Service ...7-2 Step 1 – Obtain a Returned Authorization Number ...7-2 Step 2 – Clean the Generator ...7-2 Step 3 – Ship the Generator ...7-2 Technical Specifications...A-1 Performance Characteristics...A-2 Input Power...A-2 Duty Cycle...A-2 Dimensions and Weight ...A-2 Operating Parameters...A-2 Transport and Storage ...A-2 Audio Volume...A-3 Return Electrode Sensing...A-3 Low Frequency (50-60 Hz) Leakage Current ...A-3 High Frequency (RF) Leakage Current ...A-4 Standards and IEC Classifications ...A-4 Class I Equipment (IEC 60601-1)...A-4 Type CF Equipment (IEC 60601-1) / Defibrillator Proof ...A-4 Drip Proof (IEC 60601-2-2)...A-4 Electromagnetic Interference ...A-4 Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2) ...A-4 Voltage Transients (Emergency Generator Mains Transfer) ...A-4 Output Characteristics ...A-4 Maximum Output for Monopolar and Bipolar Modes ...A-4 Output Power Curves ...A-5 Warranty ...B-1

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LIST OF FIGURES Figure 2 – 1 Figure 2 – 2 Figure 2 – 3 Figure 2 – 4 Figure 2 – 5 Figure 2 – 6 Figure 2 – 7 Figure 2 – 8 Figure 5 – 1 Figure A – 1 Figure A – 2 Figure A – 3 Figure A – 4 Figure A – 5 Figure A – 6 Figure A – 7

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Layout of controls, indicators, and receptacles on the front panel...2-2 Controls for setting and recalling presets...2-4 Controls for the Cut and Blend modes...2-5 Controls for the Coag mode ...2-6 Controls for the Bipolar mode ...2-7 Indicators for power, return electrodes, and footswitch control...2-8 Location of the unit power switch and front panel receptacles ...2-9 Layout of connectors and controls on the rear panel...2-10 Fuse holder...5-2 Output power vs impedance for Cut I mode...A-5 Output power vs impedance for Cut II mode...A-5 Output power versus impedance for Blend mode, set at Minimum...A-6 Output power versus impedance for Blend mode, set at Maximum...A-6 Output power vs impedance for Pinpoint mode...A-7 Output power vs impedance for Spray mode ...A-7 Output power vs impedance for Bipolar mode ...A-8

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INTRODUCING THE ARTHREX O.P.E.S. ELECTROSURGICAL GENERATOR This section includes the following information: ● Key Features ● Components and Accessories ● Safety

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

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KEY FEATURES The Arthrex O.P.E.S. Electrosurgical Generator includes the latest technology. This unit offers unsurpassed performance, flexibility, reliability, and convenience. It includes the following features: • Two Cut Modes, Cut I & Cut II Two cut modes give the surgeon flexibility to cut all types of tissue without losing performance. Cut I generates constant output power over a wide range of impedances. Refer to Figure A-1 in the Technical Specifications section of this guide. Cut II is a softer cut that generates constant output power over a small range of impedances. Refer to Figure A-2 in the Technical Specifications section of this guide. • Blend with 10 Settings The Blend mode is a combination of Cutting and Hemostasis. The Arthrex O.P.E.S. Electrosurgical Generator gives the surgeon freedom to adjust the desired level of blend. A setting of 1 is minimal hemostasis with maximum cutting effect. A setting of 10 is maximum hemostasis with minimal cutting effect. This adjustment is easily achieved by an incremental adjustment. Refer to Section 2, Controls, Indicators, and Receptacles, Cut and Blend Controls. The Blend mode improves the rate of targeted tissue desiccation without increasing the power delivered by the generator. • Presets The surgeon can store 10 user-defined presets for easy recall of frequently used settings. A selection of 10 factory set presets can be reset to your preferred settings. Refer to the Preset table in Section 4 of this guide. • Two levels of coagulation: Pinpoint and Spray Pinpoint provides precise control of bleeding in localized areas. Spray provides greater control of bleeding in highly vascular tissue over broad surface areas. • Return electrode sensing and contact quality monitoring The Arthrex O.P.E.S. Electrosurgical Generator incorporates a return electrode contact quality monitoring system (Bovie NEM™). This system detects the type of return electrode: solid or split. The system also continually monitors the contact quality between the patient and the split return electrode. This feature is designed to minimize patient burns at the return electrode site. • FDFS™ (Fast Digital Feedback System) The FDFS™ (Fast Digital Feedback System) measures voltage and current at 5,000 times a second and immediately adjusts the power to varying impedance during the electrosurgical procedure. The unit’s digital technology senses and responds to changes in tissue and density. Unlike analog, this feature reduces the need to adjust power settings manually. NOTICE: The Bovie NEM™ system requires that you use a split return electrode.

• Memory The unit automatically powers up to the last selected preset settings. • Isolated RF output This minimizes the potential of alternate site burns. • Standard connectors These connectors accept the latest monopolar and bipolar instruments. Refer to Section 2, Controls, Indicators, and Receptacles to learn more.

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• Self diagnostics These diagnostics continually monitor the unit to ensure proper performance. Unlike analog, this feature reduces the need to adjust power settings manually. • Hand/foot sensing This feature automatically senses that a footswitch is being used and disengages all hand control functionality. This feature eliminates the need for non hand-controlled devices. • Digital vs. analog The use of digital technology improves the sensing rate used by the generator compared to other electrosurgical generators on the market today.

COMPONENTS AND ACCESSORIES You should receive the following components with your generator: • Arthrex O.P.E.S. Electrosurgical Generator • Hospital-grade power cord (110 VAC and 220 VAC) • User’s Guide • Service Guide

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SAFETY The safe and effective use of electrosurgery depends to a large degree on factors solely under the control of the operator. There is no substitute for a properly trained and vigilant medical staff. It is important that they read, understand, and follow the operating instructions supplied with this electrosurgical equipment. At the customer’s request, Arthrex, Inc. will be happy to provide training on how to use the O.P.E.S. Electrosurgical Generator as a normal part of product purchase. Physicians have used electrosurgical equipment safely for many years in numerous procedures. Before starting any surgical procedure, the surgeon should be familiar with the medical literature, complications, and hazards of using electrosurgery in that procedure. To promote the safe use of the Arthrex O.P.E.S. Electrosurgical Generator, this section presents the warnings and cautions that appear throughout this user’s guide. It is important that you read, understand, and follow the instructions in these warnings and cautions so that you can operate this equipment with maximum safety. It is also important that you read, understand, and follow the instructions for use in this user’s guide.

WARNINGS: Hazardous Electrical Output - This equipment is for use only by trained, licensed physicians. Danger: Fire / Explosion Hazard - Do not use the Arthrex O.P.E.S. Electrosurgical Generator in the presence of flammable materials. 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 [N20] 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. Connect the power cord to a properly polarized and grounded power source with the frequency and voltage characteristics that match those listed on the back of the unit. Electric Shock Hazard - Connect the generator power cord to a properly grounded receptacle. Do not use power plug adapters. Electric Shock Hazard - Always turn off and unplug the generator before cleaning. Fire Hazard - Do not use extension cords. Patient Safety - Use the generator only if the self-test has been completed as described. Otherwise, inaccurate power outputs may result.

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WARNINGS: Failure of the high frequency electrosurgical equipment could result in an unintended increase of output power. The instrument receptacles on this generator are designed to accept only one instrument at a time. Do not attempt to connect more than one instrument at a time into a given receptacle. Doing so will cause simultaneous activation of the instruments. Use the lowest output setting necessary to achieve the desired surgical effect. Use the active electrode only for the minimum time necessary in order to lessen the possibility of unintended burn injury. 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 structures. Use electrosurgery with caution in the presence of internal or external pacemakers. Interference produced by the use of electrosurgical devices can cause devices such as pacemakers 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 for patients with cardiac pacemakers. If the patient has an Implantable Cardioverter Defibrillator (ICD), contact the ICD manufacturer for instructions before performing an electrosurgical procedure. Electrosurgery may cause multiple activation of ICDs. 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. For surgical procedures where the high frequency current could flow through parts of the body having a relatively small cross-sectional area, the use of bipolar techniques may be desirable to avoid unwanted coagulation. 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 return electrode that 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 output 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 5 to 8 cm (2 to 3 in.) of dry gauze between contact points to ensure that contact does not occur. • Position the return electrode to provide a direct current route between the surgical site and the return electrode which avoids skin-to-skin contact areas. • In addition, place patient return electrodes according to the manufacturer’s instructions. Potential for alternate site burns increases if the return electrode is compromised. Arthrex recommends the use of split return electrodes and generators with a contact quality monitoring system. Do not wrap the accessory cords or return electrode cords around metal objects. This may induce currents that could lead to shocks, fires, or injury to the patient or surgical team.

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CAUTIONS: At no time should you touch the active electrode or bipolar forceps. A burn could result. Do not stack equipment on top of the generator or place the generator on top of electrical equipment. These configurations are unstable and/or do not allow adequate cooling. Provide as much distance as possible between the electrosurgical generator and other electronic equipment (such as monitors). An activated electrosurgical generator may cause interference with them. Non-function of the generator may cause interruption of surgery. A backup generator should be available for use. Do not turn the activation tone down to an inaudible level. The activation tone alerts the surgical team when an accessory is active. When using a smoke evacuator in conjunction with the electrosurgical generator, place the smoke evacuator a distance from the generator and set the generator volume control at a level that ensures that the activation tones can be heard. The use of high frequency current can interfere with the function of other electromagnetic equipment. When high frequency surgical equipment and physiological monitoring equipment are used simultaneously on the same patient, place any monitoring electrodes as far as possible from the surgical electrodes. Monitoring systems incorporating high frequency current-limiting devices are recommended. Do not use needles as monitoring electrodes during electrosurgical procedures. Inadvertent electrosurgical burns may result. To avoid the possibility of an electrosurgical burn to either the patient or the physicians, do not allow the patient to come in contact with a grounded metal object during activation. When activating the unit, do not allow direct skin contact between the patient and the physician. Remove any loose fitting jewelry from the patient before activation. Examine all accessories and connections to the electrosurgical generator before use. Ensure that the accessories function as intended. Improper connection may result in arcs, sparks, accessory malfunction, or unintended surgical effects. When not using active accessories, place them in a holster or in a clean, dry, non-conductive, and highly visible area not in contact with the patient. Inadvertent contact with the patient may result in burns. Studies have shown that smoke generated during electrosurgical procedures can be potentially harmful to patients and the surgical team. These studies recommend adequately ventilating the smoke by using a surgical smoke evacuator or other means.1 1. U.S. Department of Health and Human Services. National Institute for Occupational Safety and Health (NIOSH). Control of Smoke from Laser / Electric Surgical Procedures. HAZARD CONTROLS, Publication No. 96-128, September, 1996).

NOTICES: If required by local codes, connect the generator to the hospital equalization connector with an equipotential cable. Do not clean the generator with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch the panels or damage the generator.

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CONTROLS, INDICATORS, AND RECEPTACLES This section describes: ● The Front and Rear Panels ● Controls, Indicators, Receptacles, and Ports

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FRONT PANEL Figure 2 – 1 Layout of controls, indicators, and receptacles on the front panel

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Symbols on the Front Panel SYMBOLS

DESCRIPTION

Cut Controls Cut Mode Blend Mode Coag Controls Pinpoint Mode Spray Mode Bipolar Controls Bipolar Mode Indicators Split Return Electrode Solid Return Electrode Regulatory Symbology Read instructions before use. Defibrillator Proof Type CF Equipment RF Isolated – patient connections are isolated from earth at high frequency. Power Switch and Handpiece Connectors Return Electrode Receptacle Caution High Voltage Cut Mode Coag Mode Monopolar Handpiece Receptacle Bipolar Mode Bipolar Handpiece Receptacle Preset Controls Recall Button Set Button

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PRESET CONTROLS Figure 2 – 2 Controls for setting and recalling presets

Preset Number Display Indicates the current selection of one of the 10 presets (0-9). Recall Button Toggles through the 10 presets. Stop at the desired number (0-9) illuminated in the Preset Number Display to recall a Preset.

Set Button Sets the desired preset into one of the 10 user-defined presets. Press and hold the Set button for three seconds to save the settings.

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Preset Indicator LED Blinks in the lower right corner of the Preset display to indicate that the current setting is not one of the user-defined presets.

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Cut and Blend Controls Figure 2 – 3 Controls for the Cut and Blend modes

Blend Amount Control Buttons Increases or decreases the amount of blend (Level 1-10) added in the Blend mode.

Cut Power Display (watts) Indicates the power set for the Cut / Blend mode.

Cut Power Control Buttons Increases or decreases the Cut or Blend power output in increments of 1 to 10 watts.

Cut I Mode Indicator Indicates when the Cut I mode is selected. Cut II Mode Indicator Indicates when the Cut II mode is selected. Cut and Blend Mode Selector Toggles between Cut I, Cut II, and Blend modes.

Blend Amount Indicator Indicates the amount of blend added in the Blend mode. More bars illuminated indicates more blend, divided into 10 steps.

Cut Activation Indicator Illuminates when Cut or Blend mode is activated.

User ’s Guide • O.P.E.S. Electrosurgical Generator

Blend Mode Indicator Indicates when the Blend mode is selected.

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Coag Controls Figure 2 – 4 Controls for the Coag mode

Coag Power Display (watts) Indicates the power set for the Coag mode.

Coag Power Control Buttons Increases or decreases the Pinpoint or Spray Coag power output in increments of 1 to 10 watts.

Coag Activation Indicator Illuminates when Coag mode is activated. Pinpoint Mode Indicator Indicates when the Pinpoint mode is selected. Pinpoint and Spray Mode Selector Toggles between Pinpoint mode and Spray mode.

Spray Mode Indicator Indicates when the Spray mode is selected.

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Bipolar Controls Figure 2 – 5 Controls for the Bipolar mode

Bipolar Power Display (watts) Indicates the power set for the Bipolar mode. Displays error code in the event of an error.

Bipolar Power Control Buttons Increases or decreases the Bipolar power output in increments of 1 to 10 watts.

Bipolar Activation Indicator Illuminates when Bipolar mode is activated.

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Indicators Figure 2 – 6 Indicators for power, return electrodes, and footswitch control

Power Indicator Illuminates when the main power is on.

Monopolar Footswitch Indicator Illuminates when monopolar footswitch control is plugged in and available.

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Split Return Electrode Indicator Illuminates when the system detects a split return electrode.

Solid Return Electrode Indicator Illuminates when the system detects a solid return electrode.

Alarm Indicator Illuminates when the system detects a return electrode alarm condition.

Bipolar Footswitch Indicator Illuminates when bipolar footswitch control is plugged in and available.

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