Bovie Aaron 3250 Electrosurgical Generator User's Guide

USER’S GUIDE

User’s Guide • Aaron 3250 i

ii Bovie / Aaron Medical

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 3250 only.

Additional technical information is available in the Aaron 3250 Service Guide.

Equipment Covered in this Manual

Aaron 3250:

Reference No.: A3250

For Information Contact

Aaron Medical • St. Petersburg, FL 33710-2902

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 O9X 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.

Bovie Aaron Part Number MC-55-104-001 Rev. 0

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.

User’s Guide • Aaron 3250 iii

TABLE OF CONTENTS

Equipment Covered in this Manual ............................................................................iii

For Information Contact .............................................................................................iii

Conventions Used in this Guide.........................................................................................iii

Introducing the Aaron 3250..................................................................................................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 3250 ...........................................................................................................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 3250 .................................................................................................5-1

Cleaning ..........................................................................................................................5-2

Periodic Inspection ..........................................................................................................5-2

Fuse Replacement ..........................................................................................................5-2

Troubleshooting ....................................................................................................................6-1 iv Bovie / Aaron Medical

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

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

User’s Guide • Aaron 3250 v

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 and Blend modes ............................................................2-4

Figure 2 – 3 Controls for the Coag mode ............................................................................2-5

Figure 2 – 4 Controls for the Bipolar mode..........................................................................2-6

Figure 2 – 5 Indicators for power, return electrodes, and footswitch control.......................2-7

Figure 2 – 6 Location of the unit power switch and front panel receptacles .......................2-8

Figure 2 – 7 Layout of connectors and controls on the rear panel......................................2-9

Figure 5 – 1 Fuse holder......................................................................................................5-2

Figure A – 1 Output power vs impedance for Cut mode .....................................................A-6

Figure A – 2 Output power versus impedance for Blend mode minimum...........................A-6

Figure A – 3 Output power versus impedance for Blend mode maximum..........................A-7

Figure A – 4 Output power vs impedance for Coagulation mode........................................A-7

Figure A – 5 Output power vs impedance for Fulguration mode.........................................A-8

Figure A – 6 Output power vs impedance for Bipolar mode................................................A-8 vi Bovie / Aaron Medical

INTRODUCING THE AARON 3250

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.

User’s Guide • Aaron 3250 1-1

KEY FEATURES

The Aaron 3250 includes the latest technology. This unit offers unsurpassed performance, flexibility, reliability, and convenience.

It includes the following features:

•T wo Mo deess,, C

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 3250 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.

The surgeon can store 10 user-defined presets for easy recall of frequently used settings.

• 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 3250 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.

Meem orryy

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.

• Self diagnostics

These diagnostics continually monitor the unit to ensure proper performance.

1-2 Bovie / Aaron Medical

COMPONENTS AND ACCESSORIES

You should receive the following components with your generator:

• Aaron 3250

• Hospital-grade power cord (110 VAC and 220 VAC)

• User’s Guide

User’s Guide • Aaron 3250 1-3

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 3250, 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 3250 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 [N

2

0] 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.

1-4 Bovie / Aaron Medical

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.

User’s Guide • Aaron 3250 1-5

1-6

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.

Bovie / Aaron Medical

CONTROLS, INDICATORS, AND RECEPTACLES

This section describes:

●

The Front and Rear Panels

●

Controls, Indicators, Receptacles, and Ports

User’s Guide • Aaron 3250 2-1

FRONT PANEL

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

2-2 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 3250.

SYMBOLS

Cut Controls

DESCRIPTION

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

User’s Guide • Aaron 3250 2-3

PRESET CONTROLS

Figure 2 – 2 Controls for setting and recalling presets

Presets 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.

Presets Indicator LED

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

2-4

NOTICES:

The Aaron 3250 incorporates 10 factory-set presets that are all set to zero and can be reset to your preferred settings.

Set and Recall are disabled while the unit is activated.

Bovie / Aaron Medical

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 Mode Indicator

Indicates when the

Cut mode is selected.

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.

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).

User’s Guide • Aaron 3250 2-5

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 Coagulation or Fulguration Coag power output in increments of 1 to 10 watts.

Coag Activation Indicator

Illuminates when Coag mode is activated.

Fulguration and

Coagulation Mode

Selector

Toggles between

Coagulation mode and Fulguration mode.

Fulguration Mode Indicator

Indicates when the Fulguration mode is selected.

Coagulation Mode Indicator

Indicates when the Coagulation mode is selected.

2-6 Bovie / Aaron Medical

BIPOLAR CONTROLS

Figure 2 – 5 Controls for the Bipolar mode

Bipolar Activation Indicator

Illuminates when Bipolar mode is activated.

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.

User’s Guide • Aaron 3250 2-7

INDICATORS

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

Monopolar Footswitch Indicator

Illuminates when monopolar footswitch control is plugged in and available.

Bipolar Footswitch Indicator

Illuminates when bipolar 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.

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.

2-8 Bovie / Aaron Medical

POWER SWITCH AND RECEPTACLES

Figure 2 – 7 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.

Monopolar Footswitching Receptacle

Accepts cables or adapters equipped with standard (Aaron #12) active plugs.

Connect footswitching accessories.

Monopolar Handswitching Receptacle

Accepts standard 3-pin handpieces.

Connect handswitching accessories.

Bipolar Receptacle

Accepts standard cables for bipolar handpieces. Connect bipolar accessories.

User’s Guide • Aaron 3250 2-9

REAR PANEL

Figure 2 – 8 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 3250.

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

2-10 Bovie / Aaron Medical

GETTING STARTED

This section includes the following information:

●

Initial Inspection

●

Installation

●

Function Checks

●

Performance Checks

User’s Guide • Aaron 3250 3-1

INITIAL INSPECTION

When you first unpack your Aaron 3250, inspect it visually:

• Look for any signs of damage.

• Verify that the shipping package contains all items listed on the packing list.

If the unit or any accessories are damaged, notify Aaron Medical’s Customer Service immediately.

Do not use any damaged equipment.

INSTALLATION

Place the Aaron 3250 on any flat surface with a tilt angle not more than 10˚. The unit relies on natural convection cooling. Do not block its bottom or rear vents. Ensure that air flows freely on all sides of the unit.

WARNING:

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.

FUNCTION CHECKS

Upon initial installation of the unit, perform the tests listed below. Refer to the figures in the previous chapter for the location of connectors and controls.

WARNING:

At no time should you touch the active electrode or bipolar forceps. A burn could result.

Setting Up the Unit

1. Verify that the Power Switch is in the Off (O) position and that no accessories are connected to the unit.

2. Connect a hospital grade power cable to the AC power cable receptacle on the back of the unit, then to a properly grounded wall outlet.

3. Connect a two-button monopolar pencil to the appropriate receptacle. The use of Aaron pencils is recommended.

4. Do not connect a patient return electrode at this time.

5. Turn the unit on by switching the power switch to the On (|)position.

Checking the Return Electrode Alarm

1. Adjust the power settings for each mode (Cut, Coag, Bipolar) to one watt.

2. Press the Coag button of the pencil. Verify that an alarm sounds for three seconds and the patient return electrode sensing alarm indicator light illuminates, indicating that no return electrode is connected to the unit.

3. Verify that adjusting the volume control on the back of the unit while the alarm is sounding does not change the alarm volume.

3-2 Bovie / Aaron Medical

Confirming Modes

Confirm that you can select each mode and adjust the power up and down.

Checking Bipolar Mode (with bipolar footswitch)

1. Plug in the Bipolar footswitch. Verify that the Bipolar footswitch indicator illuminates.

2. Press the pedal on the Bipolar footswitch. Verify that the Bipolar mode activation indicator illuminates and that the system generates the Bipolar activation tone.

3. While activating the Bipolar mode, rotate the volume control over the full range to verify that the sound is audible throughout the range.

4. Confirm that releasing the pedal returns the unit to an idle state.

Checking Monopolar Mode (with monopolar footswitch)

1. Plug in the Monopolar footswitch. Verify that the monopolar footswitch indicator illuminates.

2. Connect a solid return electrode to the return electrode receptacle. Verify that the green solid return electrode indicator illuminates.

3. Press the Cut pedal (yellow) on the footswitch. Verify that the Cut mode activation indicator illuminates and that the system generates the Cut activation tone.

4. While activating the Cut mode, rotate the volume control over the full range to verify that the sound is audible throughout the range.

5. Press the Coag pedal (blue) on the footswitch. Verify that the Coag mode activation indicator illuminates and that the system generates the Coag activation tone.

6. While activating the Coag mode, rotate the volume control over the full range to verify that the sound is audible throughout the range.

Checking Monopolar Mode (with handswitch)

1. Connect a handswitching handpiece to the Monopolar handpiece receptacle.

2. Connect a solid return electrode to the return electrode receptacle. Verify that the green solid return electrode indicator illuminates.

3. Activate, one at a time, the Cut and Coag handswitching controls. Verify that each control causes the correct indicator and tone to sound.

PERFORMANCE CHECKS

After the unit has passed the preliminary functional test, it is ready for performance testing. A qualified biomedical engineer who is thoroughly familiar with electrosurgical devices should conduct this testing. The testing should include checking all modes of operation for proper function and power output.

User’s Guide • Aaron 3250 3-3

3-4 Bovie / Aaron Medical

USING THE AARON 3250

This section contains the following procedures:

●

Inspecting the Generator and Accessories

●

Setup Safety

●

Setting Up

●

Preparing for Monopolar Surgery

●

Preparing for Bipolar Surgery

●

Activating the Unit

●

Activation Safety

CAUTIONS:

Read all warnings, cautions, and instructions provided with this generator before use.

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

User’s Guide • Aaron 3250 4-1

INSPECTING THE GENERATOR AND ACCESSORIES

Before each use of the Aaron 3250, verify that the unit and all accessories are in good working order:

• Inspect for damage to the Electrosurgical Generator and all its connections.

• Verify that the appropriate accessories and adapters are present.

• Inspect all cords and connectors for signs of wear, damage, and abrasion.

• Verify that no errors occur when you turn on the unit.

SETUP SAFETY

WARNINGS:

Hazardous Electrical Output - This equipment is for use only by trained, licensed physicians.

Electric Shock Hazard - Connect the generator power cord to a properly grounded receptacle.

Do not use power plug adapters.

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.

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.

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.

Failure of the high frequency electrosurgical equipment could result in an unintended increase of output power.

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.

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.

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.

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 return electrodes according to the manufacturer’s instructions.

Potential for alternate site burns increases if the return electrode is compromised. Bovie Aaron

Medical recommends the use of split return electrodes and Aaron generators with a contact quality monitoring system.

4-2 Bovie / Aaron Medical

CAUTIONS:

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.

NOTICE:

If required by local codes, connect the generator to the hospital equalization connector with an equipotential cable.

SETTING UP

1. Verify that the generator is Off by pressing the power switch Off (O).

2. Place the generator on a stable flat surface, such as a table, platform, or medical cart. Carts with conductive wheels are recommended. For details, refer to the procedures for your institution or to local codes. Provide at least 10 to

15 cm (4 to 6 in.) of space from the sides and top of the generator for cooling. Normally, the top, sides, and rear panel are warm when you use the generator continuously for extended periods of time.

3. Plug the generator power cord into the AC Power Cable Receptacle on the rear panel.

4. Plug the generator power cord into a grounded receptacle.

5. Turn on the generator by pressing the power switch On (|). Verify the following:

• All visual indicators and displays on the front panel illuminate.

• Activation tones sound to verify that the speaker is working properly.

6. If the self-test is successful, a tone sounds. Verify the following:

• A Cut mode is selected; a Coag mode is selected.

• Each display shows a power setting. The unit automatically powers up to the last used power settings.

• The Patient Return Electrode Alarm Indicator illuminates red.

If the self-test is not successful, an alarm tone sounds. An error code will appear in the Bipolar display, in most cases, the generator is disabled. Note the error code and refer to Section 6, Troubleshooting.

Once the self-test is successful, connect the accessories and set the generator controls. Refer to Preparing for Monopolar

Surgery or Preparing for Bipolar Surgery later in this section.

User’s Guide • Aaron 3250 4-3

PREPARING FOR MONOPOLAR SURGERY

Monopolar surgery requires a return electrode.

Applying the Return Electrode

To maximize patient safety, Bovie Aaron Medical recommends using a split return electrode and a Aaron generator with a contact quality monitoring system (Bovie NEM™).

NOTICE:

The Bovie NEM™ system recommends that you use a split return electrode.

Refer to the manufacturer’s instructions for application site and placement procedures. When using metal plate return electrodes, use a conductive gel specifically designed for electrosurgery. Select a return electrode site with good blood flow. While a properly applied electrode results in minimal tissue heating beneath the electrode, a good blood flow helps carry heat away from the site.

1. Connect the cable to the Return Electrode receptacle on the front of the unit.

The unit will automatically sense the presence of a split or solid return electrode and, if a split return electrode is used, will constantly monitor the resistance at the contact between the electrode and the patient.

2. Adjust the Blend setting to the desired amount of hemostasis (Level 1 - 10). Adjustment is preformed by pressing the up or down buttons next to the Blend setting indicator.

Select the desired power settings for Cutting. Adjustment is preformed by pressing the up or down buttons next to the Cut display.

Select the mode of operation for Coagulation, either Coagulation or Fulguration.

Select the desired power setting for Coagulation. Adjustment is preformed by pressing the up or down buttons next to the

Coag display.

Connecting Accessories

1. Connect a 3-pin monopolar device into the monopolar receptacle on the front of the unit.

If footswitching control capabilities are preferred, connect the Aaron monopolar footswitch to the appropriate footswitch connecting socket on the rear of the unit.

If you are using… Connect it to…

Standard 3-pin handswitching pencil

Footswitching pencil

Monopolar handswitching receptacle

Monopolar footswitching receptacle

To activate the Monopolar mode, depress the cut or coag button on the monopolar handpiece or the cut or coag pedal on the monopolar footswitch.

4-4 Bovie / Aaron Medical

PREPARING FOR BIPOLAR SURGERY

1. Connect a Bipolar cable to the Bipolar receptacle on the front of the unit.

2. Connect a forceps instrument to the bipolar cable.

3. Connect the bipolar footswitch to the bipolar footswitch connecting socket located on the rear of the unit.

To activate the Bipolar mode, depress the pedal on the bipolar footswitch.

SETTING AND RECALLING MEMORY PRESETS

The Aaron 3250 incorporates 10 user-defined memory preset settings for easy recall of frequently used settings in all three modes.

Memory

The Memory feature allows the Aaron 3250 (unit) to display the last selected Preset when the generator is turned on.

When activated by the handpiece or footswitch, the unit will operate in that particular mode and power setting.

The small red blinking dot in the lower right hand corner of the Preset display lets the user know that the Preset values have been adjusted. the unit.

Memory Function Overview

• The unit powers up with the last selected preset (0-9).

• Mode (Cut and Coag) membrane switches are disabled during activation.

• Blend amount control buttons are disabled during activation.

• Recall and Set membrane switches are disabled during activation.

• During activation, the activated mode can be adjusted up and or down a maximum of four steps. Refer to the following table for power increments.

POWER SETTINGS INCREMENTS

0-50 Watts

50-100 Watts

100-200 Watts

200-300 Watts

1 Watts

2 Watts

5 Watts

10 Watts

FOR INSTANCE...

The unit is activated using the same preset values as described in

Example 1 of this section.

While activated, the Cut 1 power output of 30 watts can be adjusted 4 steps down to 26 watts or 4 steps up to 34 watts. The

Pinpoint and Bipolar can be adjusted to display a different setting but can not be saved during activation.

• While operating the unit outside of a user-defined preset (small red dot will be blinking in lower right corner of the Preset display as an indicator), the unit temporarily stores the power setting for the activated mode (Cut,

Coag, or Bipolar). This temporary power setting is available until either the unit is reset, a preset is selected , or the power setting for the mode in use is adjusted and the unit is again activated.

• Presets only store one Cut mode (Cut I or Cut II, or Blend) and power setting, one Blend level (if applicable), one Coag mode (Pinpoint or Spray) and power setting, and Bipolar power setting. When storing, only the information displayed in the display windows will be saved to the unit’s memory.

User’s Guide • Aaron 3250 4-5

Setting Your Presets

Select the desired preset (0-9) by pressing the recall button.

Select the desired modes to be stored by pressing the mode membrane switches (Cut and

Coag).

If presetting the Blend mode, select the desired level of hemostasis (Blend Bar 1-10) by pressing the Blend amoun control button.

Select the desired power (Cut, Coag, and Bipolar) to be stored by using the power output up and down membrane switches.

Once all of the settings are selected, depress and hold the Set button for three seconds. To indicate the settings have been stored, the Preset Memory Number (0-9) will blink.

To recall a Preset, repeatedly press the Recall button to toggle through all of the presets.

Notices:

The Aaron 3250 incorporates 10 factory-set presets that are all set to zero and can be reset to your preferred settings.

A small red dot blinking in the lower right corner of the Preset indicator display indicates that the unit is not presently set to a user-defined preset.

Set and Recall buttons are disabled while the unit is activated.

Presets only store one Cut mode (Cut I or Cut II, or Blend) and power setting, one Blend level (if applicable), one Coag mode (Pinpoint or Spray) and power setting, and Bipolar power setting.

When storing, only the information displayed in the display windows will be saved to the unit’s memory.

Memory Feature (Last Selected Preset)

The Memory feature allows the unit to display the last selected power preset when the generator is turned on.

NOTICE:

To have a setting selection available at startup or to be one of the 10 user-defined presets, the adjustment to the mode and/or power settings must be saved by pressing the Set button on the

Preset display panel.

Examples

Examples 1 through 4 explain how the Memory and temporary memory features work and what happens when the power and/or mode is adjusted but not saved as one of the 10 Preset selections. Example 5 explains what happens when the power and/or mode is adjusted and saved as a new Preset setting:

#1. The physician performs a surgical procedure using Preset 2. The Preset has been stored with the following mode and power:

• The mode is set to Cut I

• The power setting for Cut I is 30 watts

• The power setting for Pinpoint is 15 watts

• The power setting for Bipolar is 20 watts.

The procedure is completed and the unit is switched off.

The next time the unit is switched on, the number 2 Preset will be displayed and available when the unit is activated. The number 2 Preset will be the same as the modes and settings indicated above.

#2. The physician performs a surgical procedure using Preset 2 (same as Example #1 Preset values).

He adjusts the power settings for each mode but does not store the new settings into the Preset.

4-6 Bovie / Aaron Medical

The next time the unit is switched on, the number 2 Preset will be displayed and available when the unit is activated. The number 2 Preset will be the same as the modes and settings indicated in Example #1.

#3. The physician performs a surgical procedure using Preset 2 (same as Example #1 Preset values).

He changes the settings by selecting the Cut II mode. The displayed power will remain at 30 watts. The physician then adjusts the power to 100 watts. He resumes the procedure now using Cut II at 100 watts. He then switches the mode back to Cut I. The power output returns to 30 watts as stored in the # 2 Preset. The physician switches again to the Cut II mode and the output power returns to the temporary memory of 100 watts as previously selected. The procedure is completed without saving any modes or power settings. The next time the unit is switched on, the number 2 Preset will be displayed and available when the unit is activated. The number 2 Preset will be the same as the modes and settings indicated in Example #1.

#4. The physician performs a surgical procedure using Preset 2 (same as Example #1 Preset values.).

As required in the procedure, he selects the Blend mode (the Blend Amount Indicator illuminates to one bar indicating the Blend mode can be increased to the preferred amount of blend). He adjusts the hemostasis level up to a

30% blend but does not store the new settings into the Preset. The next time the unit is switched on, the number

2 Preset will be displayed and available when the unit is activated. The number 2 Preset will be the same as the modes and settings indicated in Example #1.

#5. The physician performs a surgical procedure using Preset 2 (same as Example #1 Preset values). He adjusts the power settings for a Cut mode, a Coag mode, and a Bipolar mode and presses the Store button for three seconds to save the new settings as Preset number 2. The next time the unit is switched on, the number 2 Preset will be displayed and available when the unit is activated. The number 2 Preset will now be the last saved Preset settings for

Preset 2.

ACTIVATING THE UNIT

NOTICE:

Review Activation Safety on page 8 of this section before activating the unit. When you turn on your unit remember the following feature:

The Aaron 3250 will power up to the settings displayed when the unit was last activated. For example, if you set the Cut mode at 50 watts and activate the unit, then turn the unit off, it will automatically return to Cut at 50 watts when you turn it on again. Similarly, if you set Coagulation mode at 40 watts and activate the unit before you turn it off, it will return to Coagulation mode at

40 watts when you turn it on again.

During activation, the activated mode can be adjusted up and or down a maximum of four steps.

Refer to the following table for power increments.

1. Monopolar Cut - select the mode of operation for Cut or Blend then select the desired Cut power settings by pressing the up and down buttons next to the Cut power output display.

2. If using Blend, vary the blend setting by pressing the up and down buttons next to the blend amount indicator graph.

3. Monopolar Coag - select the mode of operation for coagulation: Coagulation or Fulguration, then select the coagulation power settings by pressing the up and down buttons next to the Coag power output display.

4. Bipolar - adjust the Bipolar power settings by pressing the up and down buttons next to the Bipolar power output display.

5. Activate the generator by pressing the appropriate button on the handpiece or pedal on the footswitch.

NOTICE:

Monopolar and bipolar footswitching operations are controlled by independent foot controls.

User’s Guide • Aaron 3250 4-7

ACTIVATION SAFETY

WARNINGS:

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.

Danger: Fire / Explosion Hazard - Do not use the Aaron 3250 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 that may accumulate in body cavities such as the bowel

• Oxygen enriched atmospheres

• Oxidizing agents (such as nitrous oxide [N

2

O] 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.

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.

4-8

CAUTIONS:

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.

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 jewelry from the patient before activation.

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

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.

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.)

Bovie / Aaron Medical

MAINTAINING THE AARON 3250

This section covers the following topics:

●

Cleaning

●

Periodic Inspection

●

Fuse Replacement

User’s Guide • Aaron 3250 5-1

Bovie Aaron Medical recommends that you complete periodic inspection and performance testing. Perform inspections and performance testing every six months. A qualified biomedical technician should conduct this testing to ensure that the unit is operating effectively and safely.

CLEANING

After each use, clean the unit.

WARNING:

Electric Shock Hazard - Always turn off and unplug the generator before cleaning.

NOTICE:

Do not clean the generator with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch the panels or damage the generator.

1. Turn off the generator, and unplug the power cord from the wall outlet.

2. Thoroughly wipe all surfaces of the generator and power cord with a mild cleaning solution or disinfectant and a damp cloth. Follow the procedures approved by your institution or use a validated infection control procedure.

Do not allow fluids to enter the chassis. Do not sterilize the generator.

PERIODIC INSPECTION

Every six months, visually inspect the Aaron 3250 for signs of wear or damage.

In particular, look for any of the following problems:

• Damage to the power cord

• Damage to the power cable receptacle

• Obvious damage to the unit

• Damage to any receptacle

• Accumulation of lint or debris in or around the unit

FUSE REPLACEMENT

Fuses for the unit reside directly below the Power Cable Receptacle on the rear of the unit.

To replace the fuses, follow this procedure:

1. Unplug the power cord from the wall outlet.

2. Remove the power cord from the Power Cable Receptacle on the rear panel.

3. To release the fuse drawer, insert a small flathead screwdriver into the slot on the drawer below the power cord receptacle. Then, slide the drawer out.

4. Remove the two fuses and replace them with new fuses with the same values.

5. Insert the fuse holder into the Power Cable Receptacle.

NOTICE:

If the unit does not display an error and does not power on, check fuses.

Figure 5 – 1 Fuse holder

5-2 Bovie / Aaron Medical

TROUBLESHOOTING

This section includes Error Code Descriptions and actions to take to resolve them.

User’s Guide • Aaron 3250 6-1

The Aaron 3250 includes automatic self-diagnostics. If the diagnostics detect an error, the system displays an error code, sounds an audible tone, and deactivates the unit output power.

Most error codes result from faults in accessories attached to the unit. The following table lists the error codes, describes the errors, and recommends actions to take to resolve the errors.

All error codes are displayed in the Bipolar display.

If the unit displays any other error code, it requires service.

Error Code Description Recommended Action

F1

F2

F3

F4

F5

F6

Cut handpiece button may be stuck

Coag handpiece button may be stuck

Cut footswitch pedal may be stuck

Coag footswitch pedal may be stuck

Bipolar footswitch pedal may be stuck

1. Turn off, then turn on the generator. Do not press buttons or activate accessory devices during the self-test.

2. If the error code reappears, disconnect all accessories.

Turn off, then turn on the generator again.

3. If the problem persists, replace the handpiece or footswitch and repeat the restart.

4. If the error code reappears, record the number and call

Aaron customer service.

Simultaneous activation error

The unit does not allow simultaneous activation of the cut and coagulation modes. The activation mode is “first come, first serve.”

This means that whichever mode is selected first will be the function the unit is activated to dispense. An example of this functionality includes, when the handpiece Cut button is pressed, the unit is activated for Cut. If a footswitch is simultaneously pressed for Coag, the unit will continue in the Cut mode as long as the handpiece Cut button is pressed. If the Cut button is released, the unit will sense an error and both functions will be disabled.

1. Release either the cut or coag button on the handpiece, or the cut or coag pedal on the footswitch.

2. If the error code reappears, record the number and contact

Aaron customer service.

E1

E2

E3

E4

E5

E6

E7

E8

Output current out of specification

Dosage voltage error

Dosage current error

DC power error

1. Turn the unit off.

2. Turn the unit on.

3. If the error code reappears, record the number and contact

Aaron customer service.

Internal temperature of a section of the unit exceeded the limit.

1. Turn the unit off.

2. Allow the unit to cool for 20 minutes.

3. Turn the unit on.

4. If the error code reappears, record the number and contact

Aaron customer service.

NEM circuit error

1. Turn the unit off.

2. Turn the unit on.

3. If the error code reappears, record the number and contact

Aaron customer service.

NOTICE:

If the unit does not power on to display an error, check fuses as described in Section 5 of this guide.

6-2 Bovie / Aaron Medical

REPAIR POLICY AND PROCEDURES

Refer to this section for information on:

●

Responsibility of the Manufacturer

●

Returning the Generator for Service

User’s Guide • Aaron 3250 7-1

RESPONSIBILITY OF THE MANUFACTURER

Bovie Aaron Medical is responsible for the safety, reliability, and performance of the generator only under the following circumstances:

• The user has followed the Installation and Setup Procedures in this User’s Guide.

• Persons authorized by Bovie Aaron Medical performed assembly operation, readjustments, modifications, or repairs.

• The electrical installation of the relevant room complies with local codes and regulatory requirements.

• Equipment use is in accordance with the Bovie Aaron Medical instructions for use.

For warranty information, refer to Appendix C - Warranty.

RETURNING THE GENERATOR FOR SERVICE

Before you return the generator, call your Bovie Aaron Medical representative for assistance. If instructed to send the generator to Bovie Aaron Medical, first obtain a Returned Goods Authorization Number. Then, clean the Generator and package securely to ensure proper protection of the unit. So as to aid in the processing of the unit, please be sure to include a reference to the Bovie Aaron Return Goods Authorization Number on the outside of the box and ship directly to Bovie Aaron Medical.

Step 1 – Obtain a Returned Goods Authorization Number

Call the Bovie Aaron Medical Customer Service Center to obtain a Returned Goods Authorization Number. Have the following information ready when you call:

• Hospital / clinic name / customer number

• Telephone number/fax number

• Department / address, city, state, and zip code

• Model number

• Description of the problem

• Type of repair to be done

• P.O. number

Step 2 – Clean the Generator

WARNING:

Electric Shock Hazard - Always turn off and unplug the generator before cleaning.

NOTICE:

Do not clean the generator with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch the panels or damage the generator.

A. Turn off the generator, and unplug the power cord from the wall outlet.

B.Thoroughly wipe all surfaces of the generator and power cord with a mild cleaning solution or disinfectant and a damp cloth. Follow the procedures approved by your institution or use a validated infection control procedure. Do not allow fluids to enter the chassis. You cannot sterilize the generator.

Step 3 – Ship the Generator

A. Attach a tag to the generator that includes the Returned Goods Authorization Number and the information (hospital, phone number, etc.) listed in Step 1 – Obtain a Returned Goods Authorization Number.

B.Be sure the generator is completely dry before you pack it for shipment. Although the preference is to have the

Generator repackaged using its original packaging, Bovie Aaron understands that this may not always be possible.

If necessary, contact Customer Service for the proper packaging to ship the unit. Please be sure to include a reference of the Bovie Aaron Return Goods Authorization Number on the outside of the box/container.

C. Ship the generator, prepaid, to the address given to you by the Bovie Aaron Medical Service Center.

7-2 Bovie / Aaron Medical

TECHNICAL SPECIFICATIONS

All specifications are nominal and subject to change without notice. A specification referred to as “typical” is within ± 20% of a stated value at room temperature (25° C / 77° F) and a nominal input power voltage.

User’s Guide • Aaron 3250 A-1

PERFORMANCE CHARACTERISTICS

Input Power

Input Voltage 100-240 VAC

Mains line frequency range (nominal): 50 - 60 Hz

Power consumption:

Fuses (two):

500 VA

6.3 A (slow blow)

Duty Cycle

Under maximum power settings and rated load conditions (Pure Cut, 300 watt @ 300 ohm load), the generator is suitable for activation times of 10 seconds ON followed by 30 seconds OFF for one hour.

The internal temperature of the unit is continuously monitored. If the temperature rises above 85 0 C, the alarm will sound and output power will be deactivated.

Dimensions and Weight

Width 31.1 cm (12.25 in.)

Height 15.3 cm (6.00 in.)

Depth

Weight

41.3 cm (16.25 in.)

< 8.75 kg (< 19 lbs)

Operating Parameters

Ambient temperature range

Relative humidity

Atmospheric pressure

Warm-up time

10° to 40° C (50° to 104° F)

30% to 75%, non-condensing

700 hPa to 1060 hPa

If transported or stored at temperatures outside the operating temperature range, allow one hour for the generator to reach room temperature before use.

Transport and Storage

Ambient temperature range

Relative humidity

Atmospheric pressure

-34˚ to 65˚ C (-29˚ to 149˚ F)

0% to 75%, condensing

500 hPa to 1060 hPa

Generator should fit on all standard Carts for monopolar generators. The device should be stored and used in a room temperature of approximately 77 0 F/25 0 C.

A-2 Bovie / Aaron Medical

Audio Volume

The audio levels stated below are for activation tones (cut, coag, and bipolar) and alarm tones (return electrode and system alarms) at a distance of one meter. Alarm tones meet the requirements for IEC 60601-2-2.

Activation Tone

Volume (adjustable)

Frequency

Duration

45 to 65 dB

Cut I: 610 Hz

Cut II: 610 Hz

Blend: 610 Hz

Pinpoint: 910 Hz

Spray: 910 Hz

Bipolar: 910 Hz

Continuous while the generator is activated

Alarm Tone

Volume (not adjustable)

Frequency

Duration

70 dB ± 5 dB

2 kHz 1 ⁄

2 seconds / 1 kHz 1 ⁄

2 seconds

2 seconds

Return Electrode Sensing

The system presents audible and visible alarms when it senses no return electrode.

Solid

Trip resistance: 0 Ω to 5 Ω ± 3 Ω

Continuous measurement:

Once the system establishes the solid return electrode resistance, an increase of 20 Ω ± 5 Ω in resistance will cause an alarm. When the alarm condition exists, the system deactivates output power.

Split

Trip resistance: 10 Ω ± 5 Ω to 135 Ω ± 10 Ω

Continuous measurement:

Once the system establishes the split return electrode resistance, an increase of 40% in resistance will cause an alarm. When the alarm condition exists, the system deactivates output power.

Low Frequency (50-60 Hz) Leakage Current

Enclosure source current, ground open

Source current, patient leads, all outputs

Sink current at high line, all inputs

< 500 µA

Normal polarity, intact ground: < 10 µA

Normal polarity, ground open: < 10 µA

Reverse polarity, ground open: < 10 µA

< 10 µA

User’s Guide • Aaron 3250 A-3

High Frequency (RF) Leakage Current

Bipolar RF leakage current

Monopolar RF leakage current (additional tolerance)

< 63 mA rms at 80 watts

< 150 mA rms

STANDARDS AND IEC CLASSIFICATIONS

Class I Equipment (IEC 60601-1)

Accessible conductive parts cannot become live in the event of a basic insulation failure because of the way in which they are connected to the protective earth conductor.

Type CF Equipment (IEC 60601-1) / Defibrillator Proof

The Aaron 3250 provides a high degree of protection against electric shock, particularly regarding allowable leakage currents. It is type CF equipment. Patient connections are isolated from earth and resist the effects of defibrillator discharge.

Drip Proof (IEC 60601-2-2)

The generator enclosure is constructed so that liquid spillage in normal use does not wet electrical insulation or other components which, when wet, are likely to affect adversely the safety of the generator.

Electromagnetic Interference

When other equipment is placed on or beneath a Aaron 3250, the unit can be activated without interference.

The generator minimizes electromagnetic interference to video equipment used in the operating room.

Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)

The Aaron 3250 complies with the appropriate IEC 60601-1-2 and IEC 60601-2-2 specifications regarding electromagnetic compatibility.

Voltage Transients (Emergency Generator Mains Transfer)

The Aaron 3250 operates in a safe manner when the transfer is made between line AC and an emergency generator voltage source.

A-4 Bovie / Aaron Medical

OUTPUT CHARACTERISTICS

Maximum Output for Monopolar and Bipolar Modes

Power readouts agree with actual power into rated load to within 20% or 5 watts, whichever is greater.

Mode

Cut I

Cut II

Blend (Max)

Coagulation

Fulguration

Bipolar

Output Power

300 W @ 300 ‰

300 W @ 300 ‰

200 W @ 300 ‰

120 W @ 500 ‰

80 W @ 500 ‰

80 W @ 150 ‰

Output Frequency

490 kHz – 5 kHz

490 kHz – 5 kHz

490 kHz – 5 kHz

490 kHz – 5 kHz

490 kHz – 5 kHz

490 kHz – 5 kHz

Repetition Rate

N / A

N / A

30 kHz – 5 kHz

30 kHz – 5 kHz

30 kHz – 5 kHz

30 kHz – 5 kHz

Vp-p max

2500 V

1500 V

3300 V

3500 V

7000 V

1000 V

Crest Factor*

(Rated Load)

1.6 – 20%

1.6 – 20%

3.5 – 20%

4.5 – 20%

6.5 – 20%

1.6 – 20%

User’s Guide • Aaron 3250 A-5

OUTPUT POWER CURVES

The curves that follow depict the changes for each mode at specific power settings.

Figure A – 1 Output power vs impedance for Cut I mode

Cut I

350

300

250

200

150

100

50

0

0 500 1000 1500 2000

Load Resistance [Ohms]

2500

300W

150W

3000

Figure A – 2 Output power versus impedance for Cut II mode

Cut II

350

300

250

200

150

100

50

0

0 500 1000 1500 2000

Load Resistance [Ohms]

300W

150W

2500 3000

A-6 Bovie / Aaron Medical

Figure A – 3 Output power versus impedance for Blend Min mode

Blend Min

250

200

150

100

50

0

0 500 1000 1500 2000

Load Resistance (Ohms)

2500

100W

200W

3000

Figure A – 4 Output power vs impedance for Blend Max mode

Blend Max 100W

200W

0 500 1000 1500 2000

Load Resistance [Ohms]

2500 3000

User’s Guide • Aaron 3250 A-7

Figure A – 5 Output power vs impedance for Coagulation mode

140

120

100

80

60

40

20

0

0 500 1000 1500 2000

Load Resistance [Ohms]

2500 3000

120W

60W

Figure A – 6 Output power vs impedance for Fulguration mode

90

80

70

60

50

40

30

20

10

0

0 500 1000 1500 2000

Load Resistance [Ohms]

2500 3000

80W

40W

A-8 Bovie / Aaron Medical

Figure A – 7 Output power vs impedance for Bipolar mode

50

40

30

20

10

0

0

90

80

70

60

Bipolar

80W

40W

500 1000 1500

Load Resistance [Ohms]

2000 2500 3000

User’s Guide • Aaron 3250 A-9

A-10 Bovie / Aaron Medical

ACCESSORIES

The accessories listed in this section are recommended for use with the Bovie Aaron 3250. Ensure all accessories are rated for at least the maximum peak output voltage of the generator.

User’s Guide • Aaron 3250 B-1

FOOTSWITCHES

A1253 Aaron IDS Monopolar Footswitch, Box/1

BV-1254 Aaron IDS Bipolar Footswitch, Box/1

A1253 BV-1254

ELECTROSURGICAL PENCILS

The standard Aaron pencils feature button, rocker and foot control available with and without holster and scratch pad. Also available is the Aaron smoke evacuation pencil (BV-ESP4). All disposable pencils are packaged individually and are sterile.

Additionally, Aaron offers a reusable pencil (ESPR). The pencil is validated to forty (40) autoclave cycles. The ESPR is shipped non–sterile or sterile.

ESP1

ESP1H

ESP1HS

ESP1N

ESP1HN

ESP6

ESP6H

ESP6HS

ESP6N

ESP6HN

ESP7

ESP7H

ESP7HS

ESP7N

ESP7HN

ESP4

ESPR

ESPRS

ESPH

ESSP

A1255A

Electrosurgical Push Button Pencil, Box/50

Electrosurgical Push Button Pencil w/Holster, Box/40

Electrosurgical Push Button Pencil w/Holster & Scratch Pad, Box/40

Electrosurgical Push Button Pencil w/Needle, Box/50

Electrosurgical Push Button Pencil w/Holster & Needle, Box/40

Electrosurgical Rocker Pencil, Box/50

Electrosurgical Rocker Pencil w/Holster,

Box/40

Electrosurgical Rocker Pencil w/Holster

& Scratch Pad, Box/40

ESP1

ESP6

ESP7

ESPR

Electrosurgical Rocker Pencil w/Needle,

Box/50

Electrosurgical Rocker Pencil w/Holster

& Needle, Box/40

Electrosurgical Foot Control Pencil,

Box/50

Electrosurgical Foot Control Pencil w/Holster, Box/40

Electrosurgical Foot Control Pencil w/Holster & Scratch Pad, Box/40

Electrosurgical Foot Control Pencil w/Needle, Box/50

Electrosurgical Foot Control Pencil w/Holster & Needle, Box/40

Cut-n-Clear™, Smoke & Fluid Evacuation Pencil, Box/5

Reusable Pencil, Non-Sterile (Top 40), Box/1

ESPH

Reusable Pencil, Sterile (Top 40), Box/5

Holster for ES Pencil (sterile), Box/40

Scratch Pads (sterile), Box/40

Adapter plug for connecting footswitching pencil to the Aaron IDS Series, Box/1 (not pictured)

ESSP

B-2 Bovie / Aaron Medical

RETURN ELECTRODES

Aaron disposable return electrodes with super adhesive gel are designed for single use with safety and quality built in.

Where reusability is requested a reusable electrode and cable are available.

ESRE A1252C

ESRS

ESREC

ESRSC

ESRE

ESRS

A1252C

ESREC

ESRSC

Disposable Split Adult Return Electrode w/o Cable, Box/50

Disposable Solid Adult Return Electrode w/o Cable, Box/50

Reusable Connecting Cord for ESRE & ESRS to A1250 & A2100, Box/1

Disposable Split Adult Return Electrode w/2.8M Cable, Box/50

Disposable Solid Adult Return Electrode w/2.8M Cable, Box/50

DISPOSABLE ACTIVE ELECTRODES

All electrodes utilize the standard 3 ⁄

32

" stainless steel shafts. All electrodes feature safety grip insulators combining patient and user safety with easy insertion into and removal from the surgical pencil. All disposable electrodes are manufactured to the highest standards.

They come individually packaged and sterile.

Blade Electrodes

ES01 Standard Blade,

Box/50

ES37

ES18

ES04

ES39

Modified Blade,

Box/25

Angled Blade, Box/25

Extended Blade,

Box/25

Extended Modified

Blade, Box/25

ES01

ES37

ES04

ES39

ES18

User’s Guide • Aaron 3250 B-3

Needle Electrodes

ES02 Standard Needle, Box/25

ES38

ES03

ES40

Modified Needle, Box/25

ES02

Extended Needle,

Box/25

Extended Modified

Needle, Box/25

ES03

ES40

Ball Electrodes

ES20 3 ⁄

16

" Ball, Box/25

ES21 5 ⁄

32

" Ball, Box/25

ES20

ES21

ES38

LLETZ ELECTRODES

All Aaron LLETZ Loop and Square electrodes feature tungsten wire for superior shape and integrity throughout the excision procedure. All loops are packaged with a unique protective shell to prevent damage during shipping. Ball electrodes are available in 3mm & 5mm sizes for fulguration and desiccation while the needle electrodes are available for pinpoint coagulation.

ES06

Ball Electrodes

ES06 Extended 3mm Ball, Box/5

ES07 Extended 5mm Ball, Box/5 ES07

Loop Electrodes

ES08 5mm X 5mm Loop, Box/5

ES09 10mm X 10mm Loop, Box/5

ES45

ES46

ES47

ES41

ES14

ES15

ES16

ES10

ES11

ES12

ES13

ES31

ES42

ES43

ES44

15mm X 8mm Loop, Box/5

15mm X 10mm Loop, Box/5

20mm X 8mm Loop, Box/5

20mm X 15mm Loop, Box/5

20mm X 20mm Loop, Box/5

20mm X 12mm Loop, Box/5

15mm x 15mm Loop, Box/5

15mm x 5mm Loop, Box/5

13mm x 13mm Loop, Box/5

10mm x 5mm Loop, Box/5

25mm x 10mm Loop, Box/5

5mm X 10mm Square, Box/5

5mm X 5 mm Square, Box/5

10mm X 4mm Square, Box/5

10mm X 8mm Square, Box/5

ES08

ES46

All sizes not pictured.

ES14

ES41

B-4 Bovie / Aaron Medical

A831

A832

A832M

A833

A835

A836

REUSABLE ACTIVE ELECTRODES

A834 Angled, Fine Needle, Box/1

A811

A830

Reusable Electrode, Box/1

Angled, Sharp Electrode, Box/1

Short Angled, Ball, Box/1

Short Straight, Ball, Box/1

Short Straight, Needle, Box/1

Long, Straight Ball, Box/1

Long, Straight Needle, Box/1

A834

A827

A826

A825

A824

A823

A822

A821

A820

BIPOLAR FORCEPS (REUSABLE)

Reusable Bipolar Forceps are available in micro,

1.0 and 2.0mm tip size and in lengths ranging from 4.5" to 8".

These forceps are guaranteed for twenty (20) cycles of autoclaving. A reusable bipolar cord is also available with quality silicone construction.

Forceps Cord, Box/1 (not pictured)

5" Straight, Fine, Smooth, Box/1

5 1 ⁄

2

" Straight, Med., Smooth, Box/1

5" Curved, Fine, Smooth, Box/1

7" Curved, Fine, Smooth, Box/1

7" Straight, Fine, Smooth, Box/1

7 1 ⁄

2

" Bayonet, Med., Smooth, Box/1

7 1 ⁄

2

" Bayonet, Fine, Smooth, Box/1

ADAPTER

A1255A Adapter plug for connecting footswitching pencil to the Aaron 1250, 2250, and 3250. (Bovie #12)

User’s Guide • Aaron 3250 B-5

B-6 Bovie / Aaron Medical

WARRANTY

Bovie Aaron Medical, warrants each product manufactured by it to be free from defects in material and workmanship under normal use and service for the period(s) set forth below.

Bovie Aaron Medical’s obligation under this warranty is limited to the repair or replacement, at its sole option, of any product, or part thereof, which has been returned to it or its Distributor within the applicable time period shown below after delivery of the product to the original purchaser, and which examination discloses, to Bovie Aaron

Medical’s satisfaction, that the product is indeed, defective.

This warranty does not apply to any product, or part thereof, which has been repaired or altered outside Bovie Aaron

Medical’s factory in a way so as, in Bovie Aaron Medical’s judgment, to affect its stability or reliability, or which has been subjected to misuse, neglect, or accident.

The warranty periods for Bovie Aaron Medical products are as follows:

• Electrosurgical Generators: Two years from date of shipment

• Mounting Fixtures (all models): Two years from date of shipment

• Footswitches (all models): Ninety days from date of shipment

• Patient Return Electrodes: Shelf life only as stated on packaging

• Sterile Single Use Accessories: Only as stated on packaging

User’s Guide • Aaron 3250 C-1

This warranty is in lieu of all other warranties, express or implied, including without limitation, the warranties of merchantability and fitness for a particular purpose, and of all other obligations or liabilities on the part of Bovie

Aaron Medical.

Bovie Aaron Medical neither assumes nor authorizes any other person to assume for it any other liability in connection with the sale or use of any of Bovie Aaron Medical’s products.

Notwithstanding any other provision herein or in any other document or communication, Bovie Aaron Medical’s liability with respect to this agreement and products sold hereunder shall be limited to the aggregate purchase price for the goods sold by Bovie Aaron Medical to the customer.

Bovie Aaron Medical disclaims any liability hereunder or elsewhere in connection with the sale of this product, for indirect or consequential damages.

This warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the

State of Florida, USA.

The sole forum for resolving disputes arising under or relating in any way to this warranty is the District Court of the

County of Pinellas, State of Florida, USA.

Bovie Aaron Medical, its dealers, and representatives reserve the right to make changes in equipment built and/or sold by them at any time without incurring any obligation to make the same or similar changes on equipment previously built and/or sold by them.

C-2 Bovie / Aaron Medical