Model 2250 User Guide Rev 2

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 2250 only. Additional technical information is available in the Aaron 2250 Service Guide.

Equipment Covered in this Manual Aaron 2250: Reference No.: A2250

For Information Contact Bovie Aaron Medical • 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.aaronmedical.com • [email protected] EU Authorized Representative: Peter J. Smith Medical Products Marketing 18 Yeates Close Thame OX9 3AR, UK Made in USA Printed in USA ©2005 Aaron Medical. All rights reserved. Contents of this publication may not be reproduced without the written permission of Aaron Medical. Aaron Part Number, MC-55-077-001 Rev. 2

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 Contact ...iii Conventions Used in this Guide...iii Introducing the Aaron 2250...1-1 Key Features ...1-2 Components and Accessories...1-2 Safety ...1-3 Controls, Indicators, and Receptacles ...2-1 Front Panel...2-2 Symbols on the Front Panel...2-3 Cut and Blend Controls ...2-4 Coag Controls ...2-5 Bipolar Controls...2-6 Indicators ...2-7 Power Switch and Receptacles...2-8 Rear Panel ...2-9 Symbols on the Rear Panel ...2-9 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 Aaron 2250 ...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 Activating the Unit ...4-5 Activation Safety...4-6 Maintaining the Aaron 2250 ...5-1 Cleaning ...5-2 Periodic Inspection ...5-2 Fuse Replacement ...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 ...7-2 iv

Bovie / Aaron Medical

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-5 Maximum Output for Monopolar and Bipolar Modes ...A-5 Output Power Curves...A-6 Accessories...B-1 Footswitches ...B-2 Electrosurgical Pencils...B-2 Return Electrodes ...B-3 Disposable Active Electrodes...B-3 Blade Electrodes...B-3 Needle Electrodes...B-4 Ball Electrodes ...B-4 LLETZ Electrodes ...B-4 Ball Electrodes ...B-4 Loop Electrodes ...B-4 Reusable Active Electrodes ...B-5 Bipolar Forceps (Reusable) ...B-5 Warranty ...C-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 5 – 1 Figure A – 1 Figure A – 2 Figure A – 3 Figure A – 4 Figure A – 5 Figure A – 6

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Layout of controls, indicators, and receptacles on the front panel...2-2 Controls for the Cut and Blend modes...2-4 Controls for the Coag mode ...2-5 Controls for the Bipolar mode...2-6 Indicators for power, return electrodes, and footswitch control...2-7 Location of the unit power switch and front panel receptacles ...2-8 Layout of connectors and controls on the rear panel...2-9 Fuse holder...5-2 Output power vs impedance for Cut mode ...A-6 Output power versus impedance for Blend mode minimum...A-6 Output power versus impedance for Blend mode maximum...A-7 Output power vs impedance for Coagulation mode...A-7 Output power vs impedance for Fulguration mode...A-8 Output power vs impedance for Bipolar mode...A-8

Bovie / Aaron Medical

INTRODUCING THE AARON 2250 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 2250 includes the latest technology. This unit offers unsurpassed performance, flexibility, reliability, and convenience. It includes the following features: • Cut Mode The Cut mode gives the surgeon flexibility to cut all types of tissue without losing performance. The Cut mode generates constant output power over a wide range of impedances. Refer to the Technical Specifications section of this guide. • Blend with 10 Settings The Blend mode is a combination of cutting and hemostasis. The 2250 gives the surgeon freedom to adjust the desired level of hemostasis. A setting of 1 is minimal blend with maximum cutting effect. A setting of 10 is maximum hemostasis (blend) 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. • Two levels of coagulation: Coagulation and Fulguration Coagulation provides precise control of bleeding in localized areas. Fulguration provides greater control of bleeding in highly vascular tissue over broad surface areas. • Return electrode sensing and contact quality monitoring The 2250 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 recommends that you use a split return electrode.

• 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. • 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 2250 • Hospital-grade power cord (110 VAC and 220 VAC) • User’s Guide

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Bovie / Aaron Medical

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 2250, 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 Aaron 2250 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. 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.

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WARNINGS: 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. Aaron Medical recommends the use of split return electrodes and Aaron 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

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Layout of controls, indicators, and receptacles on the front panel

Bovie / Aaron Medical

Symbols on the Front Panel Refer to the following table for descriptions of symbols found on the front panel of the Aaron 2250. SYMBOLS

DESCRIPTION

Cut Controls Cut Mode Blend Mode Coag Controls Coagulation Mode Fulguration 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

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CUT AND BLEND CONTROLS Figure 2 – 2

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.

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

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

Cut Mode Indicator Indicates when the Cut mode is selected.

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

Cut and Blend Mode Selector Toggles between Cut and Blend modes.

Blend Mode Indicator Indicates when the Blend mode is selected.

NOTICE: When selecting the Blend mode, the unit defaults to a setting of minimum blend (only the first bar is illuminated).

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Bovie / Aaron Medical

COAG CONTROLS Figure 2 – 3

Controls for the Coag mode

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

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

Coag Activation Indicator Illuminates when Coag mode is activated.

Coagulation Mode Indicator Indicates when the Coagulation mode is selected.

Fulguration and Coagulation Mode Selector Toggles between Coagulation mode and Fulguration mode.

User’s Guide • Aaron 2250

Fulguration Mode Indicator Indicates when the Fulguration mode is selected.

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BIPOLAR CONTROLS Figure 2 – 4

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 – 5

Indicators for power, return electrodes, and footswitch control

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

Power Indicator Illuminates when the main power is on.

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

User’s Guide • Aaron 2250

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

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

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

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POWER SWITCH AND RECEPTACLES Figure 2 – 6

Location of the unit power switch and front panel receptacles

Return Electrode Receptacle Accepts a standard return electrode plug.

Power On/Off Switch Turns the unit on or off.

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Monopolar Handswitching Receptacle Accepts standard 3-pin handpieces. Connect handswitching accessories.

Monopolar Footswitching Receptacle Accepts cables or adapters equipped with standard (Aaron #12) active plugs. Connect footswitching accessories.

Bipolar Receptacle Accepts standard cables for bipolar handpieces. Connect bipolar accessories.

Bovie / Aaron Medical

REAR PANEL Figure 2 – 7

Layout of connectors and controls on the rear panel

Symbols on the Rear Panel Refer to the following table for descriptions of symbols found on the rear panel of the Aaron 2250. SYMBOLS

DESCRIPTION Equipotential Ground Stud Non-ionizing Radiation Volume Control Danger - Explosion Risk If Used With Flammable Anesthetics. Fuse Enclosed Relay Connector Monopolar Footswitch Input Jack Bipolar Footswitch Input Jack Read Instructions Before Use

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