Aaron 1250 User manual

iUser’s Guide • Aaron 1250U

USER’S GUIDE

ii Bovie 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 1250U
Electrosurgical Generator only.

Additional technical information is available in the Aaron 1250U Electrosurgical Generator Service Manual.

Equipment Covered in this Manual

Aaron 1250U Electrosurgical Generator:
Model No.: A1250U

For Information Call

Bovie Medical • 5115 Ulmerton Road, Clearwater, Florida 33760 USA
U.S. Phone [phone] Fax [phone] • International Phone [phone] Fax [phone]
www.boviemedical.com • [e-mail]

Peter J. Smith Medical Products Marketing
18 Yeates Close
Thame OX9 3AR
United Kingdom

Made in USA
Printed in USA

©2009 Bovie Medical
All rights reserved.
Contents of this publication may not be reproduced without the written permission of Bovie Medical.

Part number, MC-55-128-001 Rev. 1

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.

iiiUser’s Guide • Aaron 1250U

TABLE OF CONTENTS

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

For Information Call....................................................................................................iii

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

Introducing the AARON 1250U Electrosurgical Generator ...............................................1-1

Key Features ...................................................................................................................1-2

Components and Accessories.........................................................................................1-2

Safety ..............................................................................................................................1-2

Controls, Indicators, and Receptacles ................................................................................2-1

Front Panel......................................................................................................................2-2

Symbols on the Front Panel............................................................................................2-3

Cut and Blend Controls ...................................................................................................2-4

Coag and Bipolar Controls ..............................................................................................2-5

Indicators .........................................................................................................................2-6

Power Switch and Receptacles.......................................................................................2-7

Rear Panel ......................................................................................................................2-8

Symbols on the Rear Panel ............................................................................................2-8

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 footswitch) ................................................................3-3

Checking Monopolar Mode (with footswitch) ..........................................................3-3

Checking Monopolar Mode (with handswitch) ........................................................3-3

Performance Checks.......................................................................................................3-3

Using the Aaron 1250U.........................................................................................................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..........................................................................................4-4

Activation Safety..............................................................................................................4-5

Activating the Unit ...........................................................................................................4-6

Maintaining the Aaron 1250U...............................................................................................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 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 BF Equipment (IEC 60601-1) / Defibrillator Proof..........................................A-4

Drip Proof (IEC 60601-2-2) .....................................................................................A-4

Electromagnetic Interference ..................................................................................A-4

Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2) ......................A-4

Voltage Transients (Emergency Generator Mains Transfer)...................................A-4

EMC Compliance ............................................................................................................A-4

Output Characteristics ....................................................................................................A-8

Maximum Output for Monopolar and Bipolar Modes ..............................................A-8

Output Power Curves......................................................................................................A-9

Warranty ................................................................................................................................B-1

vUser’s Guide • Aaron 1250U

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 Coagulation, Fulguration, and Bipolar Modes .........................2-5

Figure 2 – 4 Indicators for power, return electrodes, and footswitch control.........................2-6

Figure 2 – 5 Location of the unit power switch and front panel receptacles .........................2-7

Figure 2 – 6 Layout of connectors and controls on the rear panel........................................2-8

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

Figure A – 1 Output power vs impedance for Cut mode .....................................................A-9

Figure A – 2 Output power vs impedance for Blend mode ................................................A-9

Figure A – 3 Output power versus impedance for Coagulation modes.............................A-10

Figure A – 4 Output power versus impedance for Fulguration mode................................A-10

Figure A – 5 Output power vs impedance for Bipolar mode..............................................A-11

vi Bovie Medical

1-1User’s Guide • Aaron 1250U

INTRODUCING THE AARON 1250U
ELECTROSURGICAL GENERATOR

This section includes the following information:

Key Features

Components and Accessories

Safety

CAUTIONS

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

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

KEY FEATURES

The Aaron 1250U Electrosurgical Generator includes the latest technology. This unit offers unsurpassed perform­ance, flexibility, reliability, and convenience.

It includes the following features:

• Two levels of coagulation: Pinpoint Coagulation and Fulguration
Pinpoint Coagulation provides precise control of bleeding in localized areas.
Fulguration provides greater control of bleeding in highly vascular tissue over broad surface areas.

• Return electrode sensing and contact quality monitoring
The Aaron 1250U incorporates a return electrode contact quality monitoring system (Bovie NEM™).
This system determines the type of patient return electrode: single or split plate. The system also continually
monitors the contact quality between the patient and the split-plate return electrode. This feature is designed to
eliminate patient burns at the return electrode site.

NOTICE

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

• Memory
The unit automatically powers up to the last used modes and power settings.

• Isolated RF output
This minimizes the potential of alternate site burns.

• Standard connectors
These connectors accept the latest monopolar and bipolar instruments.

• Self diagnostics
These diagnostics continually monitor the unit to ensure proper performance.

COMPONENTS AND ACCESSORIES

To avoid incompatibility and unsafe operation, we recommend using the following Bovie brand accessories supplied
with your generator:

• Aaron 1250U Electrosurgical Generator

• Hospital-grade power cords - 09-039-001; 09-035-001

• User’s Guide

• One disposable pencil - ESP1-S

ADDITIONAL ACCESSORIES

To avoid incompatibility and unsafe operation, we recommend using the following Bovie accessories with the A1250U:

• BV-1253B - Footswitch for Monopolar and Bipolar procedures

1-2 Bovie Medical

• Three electrodes - ES20 (ball); ES02 (needle); ES01 (blade)

• One reusable grounding cord - A1252C

• Five disposable split grounding pads -ESRE-1

• ESU Series I DVD

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 1250U Electrosurgical Generator, this section presents the warnings and
cautions that appear throughout this user’s guide. So that you can operate this equipment with maximum safety,
it is important that you read, understand, and follow the instructions in these warnings and cautions. It is also
important that you read, understand, and follow the instructions for use in this user’s guide.

1-3User’s Guide • Aaron 1250U

WARNINGS

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

Danger: Fire / Explosion Hazard - Do not use the Aaron 1250U electrosurgical generator in the

presence of flammable anesthetics.

Fire / Explosion Hazard - The following substances will contribute to increased fire and
explosion hazards in the operating room:

• Flammable substances (such as alcohol based skin prepping agents and tinctures)

• Naturally occurring flammable gases which may accumulate in body cavities such as
the bowel

• Oxygen enriched atmospheres

• Oxidizing agents (such as nitrous oxide [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.

Use electrosurgery with caution in the presence of internal or external devices such as pacemak­ers or pulse generators. 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 device manufacturer or hospital Cardiology Department for further information
when use of electrosurgical appliances is planned for patients with cardiac pacemakers or other
implantable devices.

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.

1-4 Bovie Medical

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.

WARNINGS

To reduce the potential for alternate site burns, do one or more of the following:

• A

void skin-to-skin contact points, such as fingers touching leg, when positioning the patient.

• Place 5 to 8 cm (2 to 3 in.) of dry gauze between contact points to ensure that contact does
not occur.

• Position the patient return electrode to provide a direct current route between the surgical
site and the return electrode which avoids skin-to-skin contact areas.

• In addition, place patient return electrodes according to the manufacturer’s instructions.

Potential for alternate site burns increases if the return electrode is compromised. Bovie Medical
recommends the use of split patient return electrodes and Bovie Medical generators with a
contact quality monitoring system.

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

CAUTIONS

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

Do not stack equipment on top of the generator or place the generator on top of electrical
equipment. These configurations are unstable and/or do not allow adequate cooling.

Provide as much distance as possible between the electrosurgical generator and other electronic
equipment (such as monitors). An activated electrosurgical generator may cause interference
with them.

Nonfunction of the generator may cause interruption of surgery. A backup generator should be
available for use.

Do not turn the activation tone down to an inaudible level. The activation tone alerts the surgical
team when an accessory is active.

When using a smoke evacuator in conjunction with the electrosurgical generator, place the smoke
evacuator a distance from the generator and set the generator volume control at a level that
ensures that the activation tones can be heard.

The use of high frequency current can interfere with the function of other electromagnetic
equipment.

When high frequency surgical equipment and physiological monitoring equipment are used
simultaneously on the same patient, place any monitoring electrodes as far as possible from
the surgical electrodes.

Do not use needles as monitoring electrodes during electrosurgical procedures. Inadvertent
electrosurgical burns may result.

To avoid the possibility of an electrosurgical burn to either the patient or the physicians, do
not allow the patient to come in contact with a grounded metal object during activation.
When activating the unit, do not allow direct skin contact between the patient and the physician.

Remove any loose fitting jewelry from the patient before activation.

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

When not using active accessories, place them in a holster or in a clean, dry, nonconductive,
and highly visible area not in contact with the patient. Inadvertent contact with the patient may
result in burns.

1-5User’s Guide • Aaron 1250U

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.

1-6 Bovie Medical

2-1User’s Guide • Aaron 1250U

CONTROLS, INDICATORS, AND RECEPTACLES

This section describes:

The Front and Rear Panels

Controls, Indicators, Receptacles, the Fuse Drawer, and Ports

FRONT PANEL

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

2-2 Bovie Medical

SYMBOLS ON THE FRONT PANEL

Refer to the following table for descriptions of symbols found on the front panel of the Aaron 1250U.

2-3User’s Guide • Aaron 1250U

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 BF Equipment

RF Isolated – patient connections are isolated from earth at high frequency.

Power Switch and Handpiece Connectors

Patient Return Electrode

Caution High Voltage

Monopolar Output

Bipolar Output

CUT AND BLEND CONTROLS

Figure 2 – 2 Controls for the Cut and Blend Modes

2-4 Bovie Medical

NOTICE:

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

Cut

Blend

Cut

Cut Indicator

Illuminates when
Pure Cut Mode
is selected.

Cut and Blend
Activation Indicator

Illuminates when you
activate either Pure
Cut or Blend Mode.

Cut and Blend Power Control Dial

Increases or decreases the Cut or Blend
power output in increments of 1 watt.

Cut and Blend
Power Display (watts)

Indicates the power set for
the Pure Cut or Blend Mode.

Blend Indicator

Illuminates when
Blend Mode
is selected.

Cut Selector

When pressed, selects
the Pure Cut Mode.

Blend Selector

When pressed, selects
the Blend Mode.

COAG AND BIPOLAR CONTROLS

Figure 2 – 3 Controls for the Coagulation, Fulguration, and Bipolar Modes

2-5User’s Guide • Aaron 1250U

Coag

Coagulation

Fulguration

Bipolar

Coag and Bipolar
Activation Indicator

Illuminates when you
activate Coagulation,
Fulguration, or
Bipolar Mode.

Coag and Bipolar Power Control Dial

Increases or decreases the Coag or Bipolar
power output in increments of 1 watt.

Coag and Bipolar
Power Display (watts)

Indicates the power set for
any Coag or Bipolar Mode.

Coagulation Indicator

Illuminates when
Coagulation Mode
is selected.

Fulguration Indicator

Illuminates when
Fulguration Mode
is selected.

Bipolar Indicator

Illuminates when
Bipolar Mode
is selected.

Coagulation Selector

When pressed, selects
the Coagulation Mode.

Fulguration Selector

When pressed, selects
the Fulguration Mode.

Bipolar Selector

When pressed, selects
the Bipolar Mode.

INDICATORS

Figure 2 – 4 Indicators for power, return electrodes, and footswitch control

2-6 Bovie Medical

Power Indicator

Illuminates when
the unit is on.

Split-Plate Patient Return
Electrode Indicator

Illuminates when the system
detects a split plate.

Single Plate Patient Return
Electrode Indicator

Illuminates when the system
detects a single plate.

Monopolar Footswitch
Control Indicator

Illuminates when monopolar
footswitch control is selected.

Bipolar Footswitch
Control Indicator

Illuminates when bipolar
footswitch control is selected.

Patient Return Electrode
Alarm Indicator

Illuminates when the system
detects a patient return
electrode alarm condition.

Footswitch Control
Selector

When pressed, toggles
between monopolar
and bipolar foot control.

POWER SWITCH AND RECEPTACLES

Figure 2 – 5 Location of the unit power switch and front panel receptacles

2-7User’s Guide • Aaron 1250U

Power On/Off Switch

Turns the unit on or off.

Monopolar Footswitching Receptacle

Accepts cables or adapters equipped
with standard (Bovie #12) active plugs.
Connect footswitching accessories.

Bipolar Receptacle

Accepts standard cables
for bipolar handpieces.

Patient Return Electrode
Receptacle

Accepts a standard patient
return electrode plug.

Monopolar Handswitching Receptacle

Accepts standard three-pin handpieces.
Connect handswitching accessories.

REAR PANEL

Figure 2 – 6 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 1250U.

2-8 Bovie Medical

SYMBOLS DESCRIPTION

Equipotential Ground Stud

Non-ionizing Radiation

Volume Control

Danger

- Explosion Risk If Used With Flammable Anesthetics.

Fuse Enclosed

✱

Do not dispose of this device in the unsorted municipal waste stream.

Footswitch Input Jack

Read Instructions Before Use

NOTICE:

✱

Please note that infected medical devices must be disposed of as medical/biohazard waste and
cannot be included in used electronic equipment disposal/recycling programs. In addition, certain
electronic products must be returned directly to Bovie Medical. Contact your Bovie sales
representative for return instructions.

3-1User’s Guide • Aaron 1250U

GETTING STARTED

This section includes the following information:

Initial Inspection

Installation

Function Checks

Performance Checks

INITIAL INSPECTION

When you first unpack your Aaron 1250U, 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 Bovie Medical’s Customer Service immediately.
Do not use any damaged equipment.

INSTALLATION

Place the Aaron 1250U 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 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-pedal footswitch to the appropriate receptacle on the back of the unit. Use only Bovie Medical
footswitches. Although other types of footswitches may fit, they may not be compatible

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, Blend, Coagulation, Fulguration, and Bipolar) to one watt.

2. Press the Cut pedal of the footswitch. 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 Medical

CONFIRMING MODES

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

Checking Bipolar Mode (with footswitch)

1. Select Bipolar mode by pressing the Bipolar Mode selector.

2. Select Bipolar footcontrol by pressing the Footcontrol selector.

3. Verify that the Bipolar mode indicator illuminates and that the system generates the Coag tone when you press the
Coag pedal (Blue) on the footswitch.

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

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

Checking Monopolar Mode (with footswitch)

1. Select monopolar footcontrol by pressing the Footswitch Control selector until the Monopolar Footswitch Control
indicator illuminates.

2. Connect a single-plate return electrode to the return electrode receptacle. Verify that the green single-plate return
electrode indicator illuminates.

3. Press the Cut pedal (yellow) on the footswitch. Verify that the Cut and Blend 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, Fulguration, and Bipolar 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. 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.

3-3User’s Guide • Aaron 1250U

3-4 Bovie Medical

4-1User’s Guide • Aaron 1250U

USING THE AARON 1250U

This section contains the following procedures:

Inspecting the Generator and Accessories

Setup Safety

Setting Up

Preparing for Monopolar Surgery

Preparing for Bipolar Surgery

Activation Safety

Activating the Unit

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.

INSPECTING THE GENERATOR AND ACCESSORIES

Before each use of the Aaron 1250U, 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 Medical
recommends the use of split return electrodes and Bovie generators with a contact quality
monitoring system.

4-2 Bovie 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.

Connect the power cord to a wall outlet having the correct voltage. Otherwise, product damge may
result.

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 or Bipolar 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 Cut and/or Coag 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.

4-3User’s Guide • Aaron 1250U

PREPARING FOR MONOPOLAR SURGERY

Monopolar surgery requires a return electrode.

Applying the Return Electrode

Bovie Medical recommends using return electrode contact quality monitoring system (Bovie NEM™) patient return
electrodes to maximize patient safety. Using a patient return electrode without the Bovie NEM™ safety feature may
result in a patient burn.

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.

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.

Connecting Accessories

1. Connect a monopolar active electrode to the unit.

NOTICE:

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

2. If using a footswitch activated device, connect an appropriate Bovie Medical footswitch to the footswitch connect­ing socket on the rear of the unit.

PREPARING FOR BIPOLAR SURGERY

1. Select the Bipolar Mode by pressing the Bipolar Mode selector. The Bipolar Mode indiactor will illuminate.

2. Select Bipolar Foot Control by pressing the Foot Control selector.

3. Connect a Bipolar cable to the Bipolar receptacle.

4. Connect the appropriate Bovie Medical footswitch to the Footswitch receptacle on the rear of the unit.

5. Connect a forceps instrument to the Bipolar cable.

4-4 Bovie Medical

If you are using… Connect it to…

Standard 3-pin handswitching pencil Monopolar handswitching receptacle

Footswitching pencil Monopolar footswitching receptacle

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 1250U 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 devices such as pacemak­ers or pulse generators. 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 device manufacturer or hospital Cardiology Department for further information
when use of electrosurgical appliances is planned for patients with cardiac pacemakers or other
implantable devices.

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.

4-5User’s Guide • Aaron 1250U

ACTIVATING THE UNIT

When you turn on your unit, remember this feature:

• Aaron 1250U Electrosurgical Generator will power up to the last used modes and last used settings. For example,
if you set Pure Cut mode at 50 watts when you turned the unit off, it will automatically return to Pure Cut mode
at 50 watts when you turn it on again. Similarly, if you set Coagulation mode at 40 watts before you turned the
unit off, it will return to Coagulation mode at 40 watts when you turn it on again.

1. Monopolar Cut - Select the mode of operation for cut: Cut or Blend, then Select the desired Cut power settings
by rotating the Cut and Blend Power Control Dial.

2. Monopolar Coag - Select the mode of operation for coagulation: Coagulation or Fulguration, then Select the
coagulation power settings by rotating the Coagulation, Fulguration, and Bipolar Power Control Dial.

3. Bipolar - Select the mode of operation for Bipolar, then select the Bipolar power settings by rotating the
Coagulation, Fulguration, and Bipolar Power Control Dial.

4. Activate the generator by pressing the appropriate button:

NOTICES

One footswitch activates either monopolar or bipolar footswitching accessories.

If the unit is in the Bipolar Mode and the Bipolar Foot Control is selected, Monopolar Modes can
be activated via the 2 button handpiece. If the Cut Button is depressed, the unit will activate
whichever Cut Mode is displayed, either Cut or Blend. If the Coag Button is depressed, the unit
will switch to the Coagulation Mode and activate with the last used Coagulation Power Setting.
To return to the Bipolar Mode the user must press the Bipolar Selector.

4-6 Bovie Medical

To Activate... Press This... On This Device...

Monopolar

Cut or Blend Modes

Yellow Button
Yellow Pedal

Handswitching Pencil
Footswitch

Coagulation or Fulguration Modes

Blue Button
Blue Pedal

Handswitching Pencil
Footswitch

Bipolar

Any Bipolar Yellow (Cut) or Blue (Coag) Pedal Footswitch

5-1User’s Guide • Aaron 1250U

MAINTAINING THE AARON 1250U

This section covers the following topics:

●● Cleaning

●● Periodic Inspection

●● Fuse Replacement

Bovie 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 1250U 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.

5-2 Bovie Medical

Figure 5 – 1 Fuse holder

6-1User’s Guide • Aaron 1250U

TROUBLESHOOTING

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

The Aaron 1250U 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.

If the unit displays any other error code, it requires 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 Medical

Error Code Description Recommended Action

F1

(on the

Cut / Blend

display)

Handswitch or monopolar
footswitch cut 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
Bovie customer service.

F1

(on the

Coagulation /

Fulguration

Bipolar

display)

Handswitch or monopolar
footswitch coag pedal may
be stuck.

F2

Cut and Coag buttons activated
simultaneously
(pencil or footswitch)

The unit does not allow simultaneous activation of the cut and coagula­tion modes. Release either the cut or coag button on the handpiece, or
the cut or coag pedal on the footswitch.

F3

Footswitch Cut or Coag pedal
pressed while in Bipolar Foot
Control and the unit is not in
Bipolar Mode.

The unit will not allow the footswitch to activate the unit if Bipolar
footcontrol is selected, but the Bipolar Mode is not selected.

F4

Line voltage error
(Line voltage too high)

1. Turn the unit off.

2. Verify that the unit is connected to the line voltage.

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

E7

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
Bovie customer service.

7-1User’s Guide • Aaron 1250U

REPAIR POLICY AND PROCEDURES

Refer to this section for information on:

Responsibility of the Manufacturer

Returning the Generator for Service

RESPONSIBILITY OF THE MANUFACTURER

Bovie 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 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 Medical instructions for use.

For warranty information, refer to Appendix B - Warranty.

RETURNING THE GENERATOR FOR SERVICE

Before you return the generator, call your Bovie Medical representative for assistance. If instructed to send the
generator to Bovie 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 Return Goods Authorization Number on the outside of the box and ship directly to Bovie
Medical.

Step 1 – Obtain a Returned Goods Authorization Number

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

• Hospital / clinic name / customer number • Description of the problem

• Telephone number/fax number • Type of repair to be done

• Department / address, city, state, and zip code • P.O. number

• Model 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 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 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 Medical Service Center.

7-2 Bovie Medical

A-1User’s Guide • Aaron 1250U

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.

PERFORMANCE CHARACTERISTICS

Input Power

Duty Cycle

Under maximum power settings and rated load conditions (Pure Cut, 120 watt @ 500 ohm load), the generator is
suitable for activation times of 10 seconds on, 30 seconds off for one hour.

The internal temperature of the unit is continuously monitored. If the temperature rises above 850 C, the alarm will
sound and output power will be deactivated.

Dimensions and Weight

Operating Parameters

Transport and Storage

A-2 Bovie Medical

Ambient temperature range

-34˚ to 65˚ C (-29˚ to 149˚ F)

Relative humidity

0% to 75%, condensing during transport, non-condensing during storage

Atmospheric pressure

500 hPa to 1060 hPa

100 – 240 VAC

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

Power consumption: 540 VA

Fuses (two): 3.15A (Slow Blow)

Width

26 cm (10.25 in.)

Depth

30.5 cm (12 in.)

Height

15.2 cm (6 in.)

Weight

< 4 kg (< 9 lbs)

Ambient temperature range

10° to 40° C (50° to 104° F)

Relative humidity

30% to 75%, non-condensing

Atmospheric pressure

700 hPa to 1060 hPa

Warm-up time

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

Audio Volume

The audio levels stated below are for activation tones (bipolar, cut and coag) 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

Alarm Tone

Return Electrode Sensing

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

Low Frequency (50-60 Hz) Leakage Current

A-3User’s Guide • Aaron 1250U

Volume (adjustable)

40 to > 65 dB

Frequency

Cut: 610 Hz

Blend: 610 Hz

Pinpoint: 910 Hz

Spray: 910 Hz

Bipolar: 910 Hz

Duration

Continuous while the generator is activated

Volume (not adjustable)

70 dB ± 5 dB

Frequency

2 kHz 1⁄2 seconds / 1 kHz 1⁄2 seconds

Duration

2 s

Single Plate

Trip resistance: 0 Ω to 5 Ω ± 3

Ω

Continuous measurement:

Once the system establishes the single-plate 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 Plate

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

Ω

Continuous measurement:

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

Enclosure source current, ground open

< 300 µA

Source current, patient leads, all outputs

Normal polarity, intact ground: < 10 µA
Normal polarity, ground open: < 50 µA
Reverse polarity, ground open: < 50 µA

Sink current at high line, all inputs

< 20 µA

High Frequency (RF) Leakage Current

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 BF Equipment (IEC 60601-1) / Defibrillator Proof

The Aaron 1250U Electrosurgical Generator provides a high degree of protection against electric shock,
particularly regarding allowable leakage currents. It is type BF 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 an activated Aaron 1250U Electrosurgical Generator, 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 1250U Electrosurgical Generatorcomplies with the appropriate IEC 60601-1-2 and IEC 60601-2-2
specifications regarding electromagnetic compatibility.

Voltage Transients (Emergency Generator Mains Transfer)

The Aaron 1250U Electrosurgical Generator operates in a safe manner when the transfer is made between line AC
and an emergency generator voltage source.

EMC COMPLIANCE

Special precautions should be taken regarding the 1250U. Medical Electrical Equipment needs special precautions
regarding EMC and needs to be installed and put into service according to the EMC information provided in this
manual.

Understand that only the Accessories supplied with or ordered from Bovie Medical should be used with your device.
The use of Accessories, transducers, and cables other than those specified, may result in increased Emissions or
decreased Immunity of the 1250U. The 1250U and its accessories are not suitable for interconnection with other
equipment.

Portable and mobile RF communications equipment can affect Medical Electrical Equipment. The 1250U should not
be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the 1250U
should be observed to verify normal operation in the configuration in which it will be used.

A-4 Bovie Medical

Bipolar RF leakage current

< 39 mA

rms

Monopolar RF leakage current (additional tolerance)

< 150 mA

rms

A-5User’s Guide • Aaron 1250U

Recommended separation distances between portable and mobile RF

communications equipment and the 1250U.

The 1250U is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the 1250U can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the 1250U as recommended below, according to the maximum output power of the
communications equipment.

Rated maximum output

power of transmitter

W

0.01

0.1

1

10

100

separation distance according to frequency of transmitter in metres (m)

150 kHz to 80 MHz

d = [3.5

]

P

V

1

80 MHz to 800 MHz

d = [3.5

]

P

E

1

800 MHz to 2.5 GHz

d = [7

]

P

E

1

0.12 0.12 0.23

0.38 0.38 0.73

1.2 1.2 2.3

3.8 3.8 7.3

12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

Guidance and manufacturer’s declaration – electromagnetic emissions

The 1250U is intended for use in the electromagnetic environment listed below. The customer or the user
of the 1250U should assure that is is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF Emissions CISPR 11 Group 2

The 1250U must emit
electromagnetic energy in order
to perform its intended function.
Nearby electronic equipment may
be affected.

RF Emissions CISPR 11 Class A

The 1250U is suitable for use in
all establishments other than
domestic and those directly con­nected to the public low-voltage
power supply network that sup­plies buildings used in domestic
purposes.

Harmonic emissions
IEC 61000-3-2

Class A

Voltage fluctuations/flicker
emissions
IEC 61000-3-3

Complies

A-6 Bovie Medical

Guidance and manufacturer’s declaration – electromagnetic immunity

The 1250U is intended for use in the electromagnetic environment listed below. The customer or the user
of the 1250U should assure that is is used in such an environment.

Immunity test

IEC 60601

test level

Compliance level Electromagnetic environment - guidance

Electrostatic discharge
(ESD) IEC 61000-4-2

±6 kV contact
±8 kV air

±6 kV contact
±8 kV air

Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.

Electrical fast tran­sient/burst
IEC 61000-4-4

±2 kV for power
supply lines
±1 kV for
input/output lines

±2 kV for power
supply lines
±1 kV for
input/output lines

Mains power quality should be that
of a typical commercial or hospital
environment.

Surge IEC 61000-4-5

±1 kV differential
mode
±2 kV common
mode

±1 kV differential
mode
±2 kV common

Mains power quality should be that
of a typical commercial or hospital
environment.

Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11

<5 %

U

t

(>95 % dip in

Ut )

for 0.5 cycle

40 %

U

t

(60 % dip in

Ut )

for 5 cycles

70 %

U

t

(30 % dip in

Ut )

for 25 cycles

<5 %

U

t

(>95 % dip in

Ut )

for 5 sec

<5 %

U

t

(>95 % dip in

Ut )

for 0.5 cycle

40 %

U

t

(60 % dip in

Ut )

for

5 cycles

70 %

U

t

(30 % dip in

Ut )

for

25 cycles

<5 %

U

t

(>95 % dip in

Ut )

for 5 sec

Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
1250U requires continued
operation during power mains
interruptions, it is recommended
that the 1250U be powered from
an uninterruptible power supply or
a battery.

Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8

3 A/m

3 A/m

Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.

NOTE

U

t

is the a.c. mains voltage prior to application of the test level.

A-7User’s Guide • Aaron 1250U

Guidance and manufacturer’s declaration – electromagnetic immunity continued...

Immunity test

IEC 60601

test level

Compliance level Electromagnetic environment - guidance

Conducted RF
IEC 61000-4-6

3 Vrms
150 kHz to 80
MHz

3 Vrms (

V1)

Portable and mobile RF communications
equipment should be used no closer to any part
of the 1250U, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.

Recommended separation distance

d = [3.5

]

P

3

Radiated RF
IEC 61000-4-3

3 V/m
80 MHz to

2.5 GHz

3 V/m (

E1)

d = [3.5

]

P

3

80 MHz to 800 MHz

d = [7

]

P

3

800 MHz to 2.5 GHz

where

P

is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and

d

is the

recommended separation distance in metres (m)

Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,

a

should be less than the compliance level in each
frequency range.

b

Interference may occur in the vicinity of
equipment marked with the
following symbol.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicated theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location which the 1250U is used exceeds the applicable RF compliance level above, the 1250U should
be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the 1250U.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V

3

] V/m.

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 Output Power Output Frequency Repetition Rate Vp-p max

Crest Factor*
(Rated Load)

Cut 120 W @ 500

Blend 90 W @ 800

Coagulation 80 W @ 1000

Fulguration 40 W @ 1000

Bipolar 30 W @ 200

* an indication of a waveform's ability to coagulate bleeders without a cutting effect

Ω

Ω

Ω

Ω

Ω

357 kHz ± 50 kHz N / A 2.5 KV 2.9 ± 20%

357 kHz ± 50 kHz 30 kHz ± 5 kHz 3.5 KV 3.3 ± 20%

475 kHz ± 19 kHz 57 kHz ± 5 kHz 4.5 KV 5.5 ± 20%

410 kHz ± 50 kHz 25 kHz ± 5 kHz 6.5 KV 7.7 ± 20%

520 kHz ± 29 kHz 32 kHz ± 5 kHz 2.0 KV 6.9 ± 20%

A-8 Bovie Medical

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 mode

Figure A – 2 Output power vs impedance for Blend mode

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Figure A – 3 Output power versus impedance for Coagulation modes

Figure A – 4 Output power versus impedance for Fulguration mode

Figure A – 5 Output power vs impedance for Bipolar mode

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WARRANTY

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

The warranty periods for Bovie 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

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
Medical.

Bovie 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 Medical’s products.

Notwithstanding any other provision herein or in any other document or communication, Bovie 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 Medical to the customer.

Bovie 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 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.

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