Model 950 Users Guide Rev 4

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 Aaron 950 Electrosurgical Generator only. Additional technical information is available in the Aaron 950 Service Guide.

Equipment Covered in this Manual Aaron 950 Electrosurgical Generator: 110 VAC Model No.: A950 220 VAC Model No.: A950-220

For Information Call Aaron Medical, A Bovie Company • St. Petersburg, FL 33710 U.S. Phone 1-800-537-2790 Fax 1-800-323-1640 • International Phone +1-727-384-2323 Fax +1-727-347-9144 www.aaronmed.com • [email protected] EU Representative: Peter J. Smith Medical Products Marketing 18 Yeates Close Thame OX9 3AR, UK Made in USA Printed in USA ©2006 Aaron Medical, A Bovie Company. All rights reserved. Contents of this publication may not be reproduced without the written permission of Bovie / Aaron Medical. Aaron Part Number: MC-55-055-001 Rev. 4

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 ...iii For Information Call...iii Conventions Used in this Guide...iii Introducing the Aaron 950 Electrosurgical Generator ...1-1 Key Features ...1-2 Components and Accessories...1-2 Safety ...1-2 Controls, Indicators, and Receptacles ...2-1 Front Panel...2-2 Symbols on the Front Panel...2-3 Cut, Blend, and Coag Controls ...2-4 Fulguration, Bipolar, and Preset Controls ...2-5 Indicators and Receptacles...2-6 Rear and Side Panels ...2-7 Symbols on the Rear Panel ...2-7 Symbols on the Side Panel ...2-7 Getting Started ...3-1 Initial Inspection...3-2 Installing the Unit...3-2 Using the AARON 950...4-1 Inspecting the Generator and Accessories ...4-2 Setup Safety...4-2 Setting Up...4-3 Using and Understanding The Aaron 950 Memory Features ...4-4 Storing and Recalling Preset Settings...4-4 Preparing for Monopolar Surgery...4-4 Applying the Patient Return Electrode ...4-4 Preparing for Bipolar Surgery...4-5 Activation Safety...4-6 Activating the Unit ...4-7 Monopolar Activation ...4-7 Bipolar Activation...4-7 Maintaining the Aaron 950 ...5-1 Cleaning ...5-2 Periodic Inspection ...5-2 Troubleshooting ...6-1 Repair Policy and Procedures ...7-1 Responsibility of the Manufacturer...7-2 Returning the Generator for Service ...7-2 Step 1 – Obtain a Returned Goods Authorization Number...7-2 Step 2 – Clean the Generator ...7-2 Step 3 – Ship the Generator ...7-3

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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 Low Frequency (50–60 Hz) Leakage Current...A-3 High Frequency (RF) Leakage Current ...A-3 Standards and IEC Classifications ...A-4 Class I Equipment (IEC 60601-1) ...A-4 Type BF 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-5 Maximum Output for Bipolar and Monopolar Modes ...A-5 Output Power Curves...A-6 Monopolar Cut Curves ...A-6 Monopolar Coag Curves ...A-8 Bipolar Curves...A-10 Accessories...B-1 Footswitches ...B-2 Electrosurgical Pencils...B-2 Dispersive Electrodes ...B-2 Disposable Active Electrodes...B-3 Blade Electrodes...B-3 Needle Electrodes...B-3 Ball Electrodes ...B-3 LLETZ Electrodes ...B-4 Ball Electrodes ...B-4 Loop Electrodes ...B-4 Reusable Active Electrodes ...B-5 Bipolar Forceps (Reusable) ...B-5 Mounting Options...B-6 Warranty ...C-1

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LIST OF FIGURES Figure 2 – 1 Layout of controls, indicators, and receptacles on the front panel...2-2 Figure 2 – 2 Controls for the cut, blend, and coag modes ...2-4 Figure 2 – 3 Controls for the fulguration and bipolar modes and presets ...2-5 Figure 2 – 4 Indicators and receptacles...2-6 Figure 2 – 5 Layout of controls and indicators on the rear and side panels ...2-7 Figure 3 – 1 Mounting kit ...3-2 Figure 4 – 1 Setup procedures ...4-8 Figure A – 1 Output power versus impedance for cut mode...A-6 Figure A – 2 Peak voltage versus power setting for cut mode...A-6 Figure A – 3 Output power versus impedance for blend mode...A-7 Figure A – 4 Peak voltage versus power setting for blend mode...A-7 Figure A – 5 Output power versus impedance for coagulation mode ...A-8 Figure A – 6 Peak voltage versus power setting for coagulation mode ...A-8 Figure A – 7 Output power versus impedance for fulguration mode...A-9 Figure A – 8 Peak voltage versus power setting for fulguration mode ...A-9 Figure A – 9 Output power versus impedance for bipolar mode...A-10 Figure A – 10 Peak voltage versus power setting for bipolar mode...A-10

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INTRODUCING THE AARON 950 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 Aaron 950 Electrosurgical Generator includes the latest technology. This unit offers unsurpassed performance, flexibility, reliability, and convenience. It includes the following features: • Two levels of coagulation: Pinpoint Coagulation and Fulguration Pinpoint Coagulation provides precise control of bleeding in localized areas. Fulguration provides greater control of bleeding in highly vascular tissue over broad surface areas. • Presets The unit incorporates six user-defined presets for easy recall of frequently used settings. • Isolated RF output for Cut, Blend, and Coag modes This minimizes the potential of alternate site burns. • Ground Referenced RF output for Fulguration mode • Self diagnostics These diagnostics continually monitor the unit to ensure proper performance.

COMPONENTS AND ACCESSORIES You should receive the following components with your generator: • Aaron 950 Electrosurgical Generator • 50 sharp and 50 blunt non-sterile dermal tips • Five disposable electrodes (3 blades, 1 ball, 1 needle) • One reusable grounding cord • Five disposable grounding pads

• A901 Handpiece • Ten A910 handpiece drapes • Hospital-grade power cord • Wall mount bracket • User’s Guide

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. Physicians have used electrosurgical equipment safely 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 Aaron 950 Electrosurgical Generator, this section presents the warnings and cautions that appear throughout this user’s guide. So that you can operate this equipment with maximum safety, it is important that you read, understand, and follow the instructions in these warnings and cautions. It is also important that you read, understand, and follow the instructions for use in this user’s guide.

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WARNINGS: Hazardous Electrical Output - This equipment is for use only by trained, licensed physicians. Danger: Fire / Explosion Hazard - Do not use the Aaron 950 electrosurgical generator 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 [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. 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 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 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 patient 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.

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WARNINGS: 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 patient 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. 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 team.

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. Nonfunction 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, nonconductive, 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).

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NOTICES: 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, Rear, and Side Panels ● Controls, Indicators, and Receptacles

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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 The following table lists descriptions for symbols found on the front panel of the Aaron 950. SYMBOLS

DESCRIPTION

Generator Controls Cut mode Blend mode Coagulation mode High Frequency Desiccator Controls Bipolar mode Fulguration mode Presets Select next preset Set new preset Indicators RF ground referenced Defibrillator proof type BF equipment RF Isolated – patient connections are isolated from earth at high frequency. Read instructions before use. Caution - high voltage Handpiece Connectors Monopolar handpiece Patient return electrode Footswitch Bipolar forceps

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CUT, BLEND, AND COAG CONTROLS Figure 2 – 2 Controls for the cut, blend, and coag modes

Cut Mode Selector When pressed, selects the pure cut mode.

Cut Indicator Indicates when pure cut mode is selected.

Cut, Blend Active Indicator Indicates that the power has been activated in the selected mode.

Blend Mode Selector When pressed, selects the blended cut mode.

Coag, Fulguration, Bipolar Active Indicator Indicates that the power has been activated in the selected mode.

Blend Indicator Indicates when blended cut mode is selected.

RF Isolated Indicator Indicates when the RF output is isolated from the ground.

Coag Mode Selector When pressed, selects the coagulation mode.

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

Coag Indicator Indicates when coagulation mode is selected.

Power Output Control Knob Turn clockwise to increase power output, counterclockwise to decrease power output.

Bovie / Aaron Medical

FULGURATION, BIPOLAR, AND PRESET CONTROLS Figure 2 – 3 Controls for the fulguration and bipolar modes and presets

Fulguration Mode Selector When pressed, selects the fulguration mode.

Fulguration Indicator Indicates when fulguration mode is selected.

Cut, Blend Active Indicator Indicates that the power has been activated in the selected mode.

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

Bipolar Mode Selector When pressed, selects the bipolar mode.

Coag, Fulguration Bipolar Active Indicator Indicates that the power has been activated in the selected mode.

Bipolar Indicator Indicates when bipolar mode is selected. RF Ground Referenced Indicator Indicates when the RF output is ground referenced. Only applies to the fulguration mode. Presets Display Indicates which preset is selected (A-F). “b” and “d” are displayed in lowercase letters.

Presets Recall Selector When pressed, selects the next preset setting.

No Presets Indicator Dot blinks to indicate when no user defined preset is being used.

User’s Guide • Aaron 950

Presets Set Button When depressed for 2 seconds, makes the current settings the preset letter shown in the indicator window.

Power Output Control Knob Turn clockwise to increase power output, counterclockwise to decrease power output.

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INDICATORS AND RECEPTACLES Figure 2 – 4 Indicators and receptacles

Monopolar Handpiece Receptacle Accepts the Aaron A901 3-button handpiece cord.

Patient Plate Grounding Receptacle Accepts the Aaron A1202C reusable grounding cord.

Bipolar Cord Receptacle Accepts the Aaron A827EU bipolar forceps cord.

Footswitch Receptacle Accepts the Aaron A1203W footswitch cord.

Patient Plate Alarm Indicator Indicates an alarm condition regarding the patient return cord or pad.

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REAR AND SIDE PANELS

Figure 2 – 5 Layout of controls and indicators on the rear and side panels

Symbols on the Rear Panel SYMBOLS

DESCRIPTION Volume control Fuse enclosed Read Instructions Before Use

Symbols on the Side Panel SYMBOLS

DESCRIPTION Non-ionizing Radiation Danger - Explosion Risk If Used With Flammable Anesthetics.

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GETTING STARTED This section includes the following information: ● Initial Inspection ● Installing the Unit

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