Bovie Aaron Surgi-Center PRO Electrosurgical Generator User's Guide
Below you will find brief information for Electrosurgical Generator Aaron Surgi-Center PRO. The Aaron Surgi-Center PRO delivers RF energy to a variety of surgical devices to cut, coagulate, and ablate tissues. It features two cut modes, four blend levels, and three coagulation modes (Pinpoint, Spray, and Gentle). These features allow for versatile tissue manipulation, while the integrated NEM contact quality monitoring system enhances patient safety by detecting and alerting the user to potential contact issues. The Aaron Surgi-Center PRO is designed for a variety of surgical procedures, including those in general, gynecologic, orthopedic, ENT, and urological specialties.
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Aaron® Surgi-Center PRO ELECTROSURGICAL
GENERATOR
ELECTROSURGICAL GENERATOR
USER’S GUIDE
User ’s Guide • Aaron® Surgi-Center│PRO
USER’S GUIDE
i
ii Bovie Medical Corporation
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® Surgi-Center
│PRO only.
Additional technical information is available in the Aaron® Surgi-Center
│PRO Service Guide. For the latest information and technical bulletins, visit www.boviemed.com.
Equipment Covered in this Manual
User’s Guide • Aaron® Surgi-Center
│PRO
Reference No.: A2350
For Information Contact
Bovie Medical Corporation • 5115 Ulmerton Road, Clearwater, Florida 33760 USA
U.S. Phone 1-800-537-2790 Fax 1-800-323-1640 • International Phone +1-727-384-2323 Fax +1-727-347-9144 www.boviemed.com • [email protected]
Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
Made in USA
Printed in USA
©2015 Bovie Medical Corporation. All rights reserved. Contents of this publication may not be reproduced without the written permission of Bovie Medical Corporation.
Bovie® Part Number MC-55-232-001 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® Surgi-Center│PRO iii
TABLE OF CONTENTS
Equipment Covered in this Manual ............................................................................iii
For Information Contact .............................................................................................iii
Conventions Used in this Guide ........................................................................................iii
Introducing the Aaron® Surgi-Center│PRO.......................................................................1-1
Indications for Use ..........................................................................................................1-2
Operating Principle..........................................................................................................1-2
Intended Use...................................................................................................................1-2
Safety ..............................................................................................................................1-2
Contraindications.............................................................................................................1-6
Application Specification .................................................................................................1-6
Key Features...................................................................................................................1-7
Components and Accessories.........................................................................................1-9
Additional Accessories ....................................................................................................1-9
Controls, Indicators, and Receptacles................................................................................2-1
Front Panel......................................................................................................................2-2
Symbols on the Front Panel....................................................................................2-2
Preset Controls................................................................................................................2-4
Monopolar Power Output Modes ....................................................................................2-5
Coag Controls .................................................................................................................2-6
Bipolar Mode ..................................................................................................................2-7
Indicators.........................................................................................................................2-8
Power Switch and Receptacles.......................................................................................2-9
Rear Panel ....................................................................................................................2-10
Symbols on the Rear Panel ..................................................................................2-10
Getting Started ......................................................................................................................3-1
Initial Inspection ..............................................................................................................3-2
Installation .......................................................................................................................3-2
Function Checks..............................................................................................................3-2
Setting Up the Unit ..................................................................................................3-2
Checking the Return Electrode Alert .......................................................................3-2
Preliminary Performance Checks....................................................................................3-3
Using the Aaron® Surgi-Center│PRO ................................................................................4-1
Inspecting the Generator and Accessories .....................................................................4-2
Setup Safety....................................................................................................................4-2
Confirming Modes ...........................................................................................................4-3
Checking Bipolar Mode (with bipolar footswitch) ....................................................4-3
Checking Monopolar Mode (with monopolar footswitch) ........................................4-4
Checking Monopolar Mode (with handpiece)..........................................................4-4
Setting Up for Surgery.....................................................................................................4-4
Preparing for Monopolar Surgery....................................................................................4-5
Applying the Return Electrode ................................................................................4-5
Selecting and Adjusting the Power..........................................................................4-5
Connecting Accessories ..........................................................................................4-6
Blend Controls.........................................................................................................4-6
Preparing for Bipolar Surgery..........................................................................................4-6
Setting and Recalling RF Memory Presets .....................................................................4-6
RF Memory..............................................................................................................4-6
Memory Function Overview.....................................................................................4-7
Setting Your Presets................................................................................................4-7
Memory Feature (Last Selected RF Preset) ...........................................................4-8
iv Bovie Medical Corporation
Activating the Unit ...........................................................................................................4-8
Activation Safety..............................................................................................................4-8
Maintaining the Aaron® Surgi-Center│PRO ......................................................................5-1
Cleaning ..........................................................................................................................5-2
Periodic Inspection..........................................................................................................5-2
Fuse Replacement ..........................................................................................................5-2
Troubleshooting ....................................................................................................................6-1
System Fault Code Messages ........................................................................................6-2
System Fatal Error Messages.........................................................................................6-3
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.................................................................................................................A-2
Storage....................................................................................................................A-2
Audio Volume..........................................................................................................A-3
Return Electrode Sensing .......................................................................................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
Spill Resistance (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
EMC Compliance ............................................................................................................A-5
Output Power Curves .....................................................................................................A-9
Warranty ................................................................................................................................B-1
User ’s Guide • Aaron® Surgi-Center│PRO v
LIST OF FIGURES
Figure 2 – 1 Layout of controls, indicators, and receptacles on the front panel..................2-2
Figure 2 – 2 Layout of connectors and controls on the rear panel....................................2-10
Figure 5 – 1 Fuse holder......................................................................................................5-2
Figure A – 1 Output power versus impedance for Cut I mode ..........................................A-12
Figure A – 2 Output power versus impedance for Cut II mode .........................................A-12
Figure A – 3 Output power versus impedance for Blend (1, 2, 3, 4) mode.......................A-13
Figure A – 4 Output power vs impedance for Pinpoint mode............................................A-13
Figure A – 5 Output power vs impedance for Spray mode ...............................................A-14
Figure A – 6 Output power vs impedance for Gentle Coag mode ....................................A-14
Figure A – 7 Output power vs impedance for Macro Bipolar modee ................................A-15
Figure A – 8 Output power vs impedance for Micro Bipolar mode....................................A-15
Figure A – 9 Output power vs impedance for Standard Bipolar mode..............................A-16
vi Bovie Medical Corporation
INTRODUCING THE AARON® SURGI-CENTER
│PRO
This section includes the following information:
●
Indications for Use
●
Operating Principle
●
Intended Use
●
Safety
●
Contraindications
●
Application Specification
●
Key Features
●
Components and Accessories
●
Additional Accessories
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® Surgi-Center│PRO 1-1
INDICATIONS FOR USE
The Aaron® Surgi-Center
│PRO Electrosurgical Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue. For the latest user information and technical bulletins, visit www.boviemed.com.
OPERATING PRINCIPLE
RF energy is generated and passed through an interconnecting cable to an accessory where the energy is delivered to cut, coagulate and ablate tissue.
INTENDED USE
The Aaron® Surgi-Center
│PRO Electrosurgical Generator is intended for cutting, coagulation, ablation of tissue in general, gynecologic, orthopedic, ENT and urological procedures performed in an operating suite and procedure room.
NOTICE:
The Aaron® Surgi-Center│PRO is not intended for Tubal Ligation.
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® Surgi-Center
│PRO, 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® Surgi-Center│PRO 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.
To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
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.
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No modification of this equipment is allowed.
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.
Active cord removal during activation could result in a shock to the operator at the generator connector plug interface should activation occur by footswitch.
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.
No modification of this equipment is allowed.
Failure of the high frequency electrosurgical equipment could result in an unintended increase of output power.
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 of the RF Electrosurgical Generator at minimal power setting to get the expected clinical effect and for a normal clinical procedure time will not cause a surface skin temperature under the
Bovie ESREC, ESRSC or ESRE patient return pads to rise above 41°C when the skin is prepared properly and the pad is attached properly. However be aware that extended surgical times particularly at high power will cause a continued temperature rise at the skin and return pad interface due to RF current return to the generator.
The output power selected should be as low as possible for the intended purpose. Certain devices or accessories may present a safety hazard at low power settings.
When HF SURGICAL EQUIPMENT and physiological monitoring equipment are used simultaneously on the same PATIENT, any monitoring electrodes should be placed as far as possible from the surgical electrodes. In all cases, monitoring systems incorporating HIGH FREQUENCY current limiting devices are recommended.
Accessories must be connected to the proper receptacle type. In particular, bipolar accessories must be connected to the Bipolar Instrument output jack only. Improper connection may result in inadvertent generator activation.
Avoid using power settings that would exceed the H.F. peak voltage that is acceptable for each accessory. Choose only accessories that will withstand each mode and power setting.
To avoid incompatibility and unsafe operation, use suitable cables, accessories, active and neutral electrodes, including values for the highest allowed H.F. peak voltage.
Some accessories have multiple buttons that can deliver different surgical effects. Verify accessory features and proper mode settings prior to activation.
Connected accessories need be rated for at least the maximum peak output voltage of the H.F.
generator set at the intended output control setting in the intended operating mode.
Associated equipment and accessories used must be rated to withstand the combination of the maximum Vpeak rating and Crest Factor for the following RF modes: Blend, Pinpoint and Spray.
The output power selected should be as low as possible for the intended purpose. Certain devices or accessories may present a safety hazard at low power settings.
Apparent low output or failure of the IDS-210 RF to function correctly at the normal operating settings may indicate faulty application of the neutral electrode or poor contact in its connections. In this case, the application of the neutral electrode and its connections should be checked before selecting a higher output power.
When using Cut mode, associated equipment and active accessories should be selected that have
User ’s Guide • Aaron® Surgi-Center│PRO 1-3
1-4
a rated accessory voltage equal to or greater than 1000 Vpeak max.
When using Blend mode, associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 1870 Vpeak max.
When using Coagulation mode, associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 4000 Vpeak max.
When using Bipolar mode, associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 600 Vpeak max.
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.
The entire area of neutral electrode should be reliably attached to patient's body and as close to operating field as possible. Refer to instructions for use.
The PATIENT should not come into contact with metal parts which are earthed or which have an appreciable capacitance to earth (for example operating table supports, etc.).
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 skinto-skin contact points is concentrated and may cause a burn. This is true for grounded, ground referenced, and isolated output generators.
When HF SURGICAL EQUIPMENT and physiological monitoring equipment are used simultaneously on the same PATIENT, any monitoring electrodes should be placed as far as possible from the surgical electrodes.
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. Bovie Medical
Corporation recommends the use of split return electrodes and Bovie® 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.
The PATIENT leads should be positioned in such a way that contact with the PATIENT or other leads is avoided.
Minor neuromuscular stimulation is possible when arcs between the ACTIVE ELECTRODE and tissue occur. The generator has been designed to minimize the possibility of neuromuscular stimulation.
Accessories must be connected to the proper receptacle type. In particular, bipolar accessories must be connected to the Bipolar Instrument output jack only. Improper connection may result in unsafe generator power output.
For all Monopolar modes, any associated equipment and active electrodes must be rated to with
Bovie Medical Corporation
stand the combination of output voltage, vp-p and crest factor as stated in Appendix A of this manual.
The output power selected should be as low as possible for the intended purpose. Certain devices or ACCESSORIES may present an unacceptable RISK at low power settings.
Failure of the HF SURGICAL EQUIPMENT could result in an unintended increase of output power.
Unless a compatible MONITORING NE is used with a CONTACT QUALITY MONITOR, loss of safe contact between the NE and the PATIENT will not result in an auditory alarm.
The use of flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and oxygen should be avoided if a surgical procedure is carried out in the region of the thorax or the head, unless these agents are sucked away.
Non-flammable agents should be used for cleaning and disinfection wherever possible.
Flammable agents used for cleaning or disinfecting, or as solvents of adhesives, should be allowed to evaporate before the application of HF surgery. There is a risk of pooling flammable solutions under the patient or in body depressions such as the umbilicus, and in body cavities such as the vagina. Any fluids pooled in these areas should be mopped up before HF surgical equipment is used. Attention should be called to the danger of ignition of endogenous gases.
Some materials, for example cotton, wool and gauze, when saturated with oxygen may be ignited by sparks produced in Normal Use of the HF surgical equipment.
The generator is equipped with a return electrode sensing and contact quality monitoring system
(NEM), which monitors the quality of the patient return electrode connection. When a correctly functioning single plate return electrode is connected to the generator, the NEM (contact quality monitor) verifies the connections between the generator and the single return electrode. It DOES
NOT verify that a single return electrode is in contact with the patient. When using a split return electrode, the NEM (contact quality monitor) confirms the total resistance is within the preset safety range. Proper application (such as hydrating the patient’s skin) and visual inspection of the patient return electrode is required for safe operation.
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.
User ’s Guide • Aaron® Surgi-Center│PRO 1-5
To avoid the possibility of a burn to the patient, when using a split pad do not activate the unit if the solid pad indicator is illuminated green or the red alarm indicator remains illuminated red. This could indicate improper pad placement or a faulty NEM (contact quality monitor) circuit.
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.
CONTRAINDICATIONS
The use of the Aaron® Surgi-Center
│PRO is contraindicated in the presence of flammable anesthetics, oxygen-enriched or explosive atmospheres.
APPLICATION SPECIFICATION
Ambient luminance range
Viewing distance
Viewing angle
100 lx to 1,500 lx
20 cm to 200 cm normal to the display ± 30˚
Operating Conditions
Conditions of Visibility
RF energy is generated and passed through an interconnecting cable to an accessory where the energy is delivered to cut, coagulate and ablate tissue.
Medical purpose/indication
• Cut, coagulate, and/or ablate tissue to aid surgeon, physician or clinician in performing required procedure.
• Aids healing by preventing loss of body fluids, reduces amount of open tissue surfaces susceptible to bacterial infection.
Site of Use
• Tissue
Site Condition
• Clean and protect from infection from start through completion of procedure
Patient Population
– * Patient should not be user.
• Age: Infant to geriatric
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• Weight: No restriction
• Patient State: Alert, relaxed, may be sedated, having had local anesthetic applied.
Intended User Profile
• Education – Trained physician, physician’s assistant, nurse, nurse practitioner, clinician.
• Knowledge: No maximum
- Minimum:
- Understands electrosurgery and electrosurgical techniques;
- Read and understands supplied User’s Guide (Accompanying Document)
- Understands hygiene
- Maximum:
- There is no maximum
• Language Understanding:
- Languages as specified in the marketing distribution plan
• Experience:
- Minimum:
- Some training on techniques or training under surveillance/supervision
- No special experience needed
- Maximum:
- There is no maximum
- Permissible Impairments:
- Mild reading / vision impairment or vision correction to 20/20
- Impaired by 40% resulting in 60% of normal hearing at 500 Hz to 2.0 kHz.
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.
KEY FEATURES
The Aaron® Surgi-Center
│PRO includes the latest technology. This unit offers unsurpassed performance, flexibility, reliability, and convenience.
It includes the following features:
• Two Cut Modes, Cut I & Cut II
Two cut modes give the surgeon flexibility to cut all types of tissue without losing performance.
Cut I generates constant output power over a wide range of impedances. Refer to Appendix A, Technical Specifications section of this guide.
Cut II is a softer cut that generates constant output power with a lower voltage over a small range of impedances suggested for laparoscopic procedures. Refer to Appendix A, Technical Specifications section of this guide.
• Four Levels of Blend
The Blend mode is a combination of cutting and hemostasis. The IDS-210™ gives the surgeon freedom to adjust the desired level of hemostasis. A level setting of 1 is minimal blend with maximum cutting effect. A level setting of 4 is maximum hemostasis
(blend) with minimal cutting effect. This adjustment is easily achieved by a incremental 4-level 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.
• Three levels of coagulation: Pinpoint, Spray and Gentle Coagulation
–
Pinpoint provides precise control of bleeding in localized areas.
User ’s Guide • Aaron® Surgi-Center│PRO 1-7
– Spray provides greater control of bleeding in highly vascular tissue over broad surface areas.
– Gentle provides a more intense coagulation than in other modes. For instance, when Coagulation is necessary in short amounts
of time, reduced electrode carbonization is provided.
• Macro Bipolar Mode
The Macro Bipolar Mode provides delicate Bipolar coagulation effects to prevent tip tissue adhesion and carbonization.
• Micro Bipolar Mode
The Micro Bipolar Mode provides precise Bipolar coagulation effects.
• Standard Bipolar Mode
The Standard Bipolar Mode provides power for conventional Bipolar output.
• Three Bipolar Modes
For procedures requiring Bipolar output power, the generator offers the surgeon three Bipolar modes (Macro, Micro and
Standard).
• Presets
The surgeon can store 10 user-defined RF presets and 6 interface Set-Up Preferences presets for easy recall of frequently used settings.
• Return electrode sensing and contact quality monitoring
The IDS-210™ 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.
NOTICES:
The Bovie NEM™ system recommends that you use a split return electrode.
Before activation, pad placement and visual verification of the split return electrode (split pad) indicator on the front panel is recommended. After connecting the split pad to the generator and placing the split pad securely to the patient, give the unit 3 seconds to recognize the split pad. The split pad indicator will illuminate green. If the split pad and cord are attached to the generator without secure contact to the patient, the alarm indicator will illuminate red.
• FDFS TM (Fast Digital Feedback System)
The FDFS TM (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 density. Unlike analog, this feature reduces the need to adjust power settings manually with varying tissue impedance.
• User-Friendly Design
Digital interface with membrane switch feature selection.
• Three Front Panel Accessory Connections and Two Rear Panel Footswitch Connections
These connectors accept the latest monopolar and bipolar instruments. Refer to Section 2, Controls, Indicators, and Receptacles to learn more. Monopolar 1 connector accepts a standard 3-pin monopolar connector or a single-pin IDS-210 monopolar Foot-
Control Adapter (A1210A) used with the (A1210D or A1210R monopolar Cable) for footcontrolled accessories. Monopolar 2 connector accepts a standard 3-pin monopolar connector for connecting standard monopolar accessories to the generator. The rear panel monopolar footswitch connector accepts a Bovie® Monopolar Footswicth (BV-1253B). The rear panel bipolar footswitch connector accepts a Bovie® Bipolar Footswitch (BV-1254B).
• Memory
The unit automatically powers up to the last activated mode and power settings.
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• Isolated RF output
This minimizes the potential of alternate site burns.
• 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® Surgi-Center
│PRO
• Hospital-grade power cord (120 VAC - 09-039-001 and 240 VAC - 09-035-001)
• User’s Guide - 55-231-001
ADDITIONAL ACCESSORIES
To avoid incompatibility and unsafe operation, we recommend using the following Bovie
® accessories with the Aaron® Surgi-Center
│PRO:
• BV-1253B - Monopolar Footswitch
• BV-1254B - Bipolar Footswitch
• A1210A - Monopolar Foot-Control Instrument Adapter
• A1210D - Disposable Monopolar Foot-Control Instrument Cable
• A1210R - Reuseable Monopolar Foot-Control Instrument Cable
• BV-IDS-CS - Mobile Cart Stand
• A827V - Bipolar Cable
• ESP Line of Monopolar Handpieces
User ’s Guide • Aaron® Surgi-Center│PRO 1-9
1-10 Bovie Medical Corporation
CONTROLS, INDICATORS, AND RECEPTACLES
This section describes:
●
The Front and Rear Panels
●
Controls, Indicators, Receptacles, and Ports
User ’s Guide • Aaron® Surgi-Center│PRO 2-1
FRONT PANEL
Figure 2 – 1 Layout of controls, indicators, and receptacles on the front panel
Symbols on the Front Panel
Refer to the following table for descriptions of symbols found on the front panel of the Aaron® Surgi-Center
│PRO.
SYMBOLS
Cut Controls
DESCRIPTION
Cut Modes (Cut I and Cut II)
Blend Mode
Coag Controls
Pinpoint Mode
Spray Mode
Gentle Mode
Bipolar Controls
Macro Bipolar Mode
Micro Bipolar Mode
Standard Bipolar Mode
2-2 Bovie Medical Corporation
Symbols on the Front Panel Continued
Refer to the following table for descriptions of symbols found on the front panel of the Aaron® Surgi-Center
│PRO.
SYMBOLS
Selection
DESCRIPTION
Select / Toggle / Adjust Settings
Recall
Set
Indicators
Split Return Electrode
Solid Return Electrode
Regulatory Symbology
Mandatory: Refer to instruction manual / guide
Defibrillator Proof Type CF Equipment
RF Isolated – patient connections are isolated from earth at high frequency.
Warning: Dangerous voltage
Power Switch and Receptacles
Power OFF
Power ON
Return Electrode (Split)
Return Electrode (Solid)
Monopolar Handpiece 1 - (for 3-pin monopolar connection)
Monopolar Handpiece 1 - (for single plug monopolar connection)
Monopolar Handpiece 2
Bipolar Handpiece
User ’s Guide • Aaron® Surgi-Center│PRO 2-3
PRESET CONTROLS
Recall Button
Toggles through the 10 RF presets or 6 Bipolar setup preferences.
Set Button
Sets the desired preset into one of the 10 user-defined presets or the 6
Bipolar setup preferences. Press and hold the Set button for three seconds to save the settings.
Preset / SetUp Preferences Display
Preset indicates the current selection of one of the 10
RF presets (0-9). Indicates the current selection of one of the 6 Bipolar Setup Preferences presets (a-f) in
Bipolar “setup”. Also indicates a dash “–” when a
Preset is not selected.
Preset Indicator LED
Blinks in the lower right corner of the Preset display to indicate that the current setting is not one of the user-defined presets.
2-4
NOTICES:
The Aaron® Surgi-Center│PRO incorporates 10 RF presets that are factory set to zero watts and can be programmed to your preferred settings.
Set and Recall are disabled while the unit is activated.
Bovie Medical Corporation
MONOPOLAR POWER OUTPUT MODES
Blend Level Control Buttons
Increases or decreases the blend Level (1-4) only applicable to the Blend mode.
Monopolar Cut Power Display
(watts)
Indicates the power set for the selected Cut / Blend mode.
Displays error/fault code in the event of an error or fault.
Cut and Blend Power Control Buttons
Increases or decreases the selected Cut mode output power setting.
Cut I Mode Indicator
Illuminates green when the
Cut I mode is selected.
Blend Mode Level
Indicator
Indicates the level of blend.
Cut Activation Indicator
Illuminates when Cut or
Blend mode is activated.
(illuminates yellow)
Cut II Mode Indicator
Illuminates green when the
Cut II mode is selected.
Blend Mode Indicator
Illuminates green when the
Blend mode is selected.
Cut and Blend
Mode Selector
Toggles between
Cut I, Cut II, and
Blend modes.
User ’s Guide • Aaron® Surgi-Center│PRO 2-5
COAG CONTROLS
Coag Power Display (watts)
Indicates the power set for the selected Coag mode.
Displays error/fault codes in the event of an error or fault.
Coag Power Control Buttons
Increases or decreases the selected
Coag mode output power setting.
Coag Activation Indicator
Illuminates when Coag mode is activated.
(illuminates blue)
Pinpoint Mode Indicator
Illuminates green when the
Pinpoint mode is selected.
Gentle Mode Indicator
lluminates green when the
Gentle mode is selected.
Spray Mode Indicator
lluminates green when the
Spray mode is selected.
Pinpoint, Spray and Gentle Mode
Selector
Toggles between
Pinpoint mode,
Spray mode and
Gentle mode.
2-6 Bovie Medical Corporation
BIPOLAR POWER OUTPUT MODES
Bipolar Power Display (watts)
Indicates the power set for the
Bipolar modes.
Displays error/fault codes in the event of an error or fault.
Bipolar Power Control Buttons
Increases or decreases the output power setting for the selected
Bipolar mode.
Bipolar Activation Indicator
Illuminates when the Bipolar mode is activated.
(illuminates blue)
Macro Mode Indicator
Illuminates green when the
Macro Bipolar mode is selected.
Micro Mode Indicator
Illuminates green when the
Micro Bipolar mode is selected.
Standard (Std) Mode
Indicator
Illuminates green when the
Standard Bipolar mode is selected.
Bipolar Mode Selector
Toggles between Macro,
Micro, Standard and
Bovie® Bipolar modes.
User ’s Guide • Aaron® Surgi-Center│PRO 2-7
INDICATORS
Power Indicator
Illuminates green when the main power is on.
Solid Return
Electrode Indicator
Illuminates green when the system detects a single plate.
Solid pad indicator only detects that a pad is connected to the unit. The unit does not monitor pad placement on the patient.
Split Return
Electrode Indicator
Illuminates green when the system detects a split plate is properly placed on the patient.
Alarm Indicator
Illuminates red when the system detects a return electrode alarm condition.
2-8 Bovie Medical Corporation
POWER SWITCH AND RECEPTACLES
Return Electrode
Receptacle
Accepts a standard return electrode plug.
Power On/Off Switch
Turns the unit on or off.
Monopolar 2 Handswitching Receptacle
Accepts standard 3-pin handpieces. Connect handswitching accessories.
Monopolar 1 Handswitching/ Footswitching
Receptacle
Accepts standard 3-pin handpieces or accepts footswitching adapter (A1210A) or cable
(A1210D or A1210R). Connect handswitching accessories.
Bipolar Receptacle
Accepts standard cables for bipolar handpieces. Connect bipolar accessories.
User ’s Guide • Aaron® Surgi-Center│PRO 2-9
REAR PANEL
Figure 2 – 2 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® Surgi-Center
│PRO.
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 (Far left)
Bipolar Footswitch Input Jack
Manufacturer
Caution, Consult Accompanying Documents
2-10
Do Not Dispose of Unit in Municipal Waste Stream.
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 Corporation. Contact your Bovie® sales representative for return instructions.
Bovie Medical Corporation
GETTING STARTED
This section includes the following information:
●●
Initial Inspection
●●
Installation
●●
Preliminary Function Checks
●●
Preliminary Performance Checks
User ’s Guide • Aaron® Surgi-Center│PRO 3-1
INITIAL INSPECTION
When you first unpack your Aaron® Surgi-Center │PRO™, 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 Corporation’s Customer Service immediately.
Do not use any damaged equipment.
INSTALLATION
Place the Aaron® Surgi-Center │PRO™ 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.
Do not position unit so that it is difficult to disconnect the power cord from the power source.
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.
NOTICE:
The use of Bovie® accessories is recommended. Refer to accessory Instructions For Use for specific instructions concerning use and safety.
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.
3. Plug the power cable into to a properly grounded wall outlet.
4. Turn the unit on by switching the power switch to the On (—)position. Verify self-test is completed and successful by:
• A series of test tones completes
• All Indicators illuminate (except Ammeter)
• All digital displays display 8’s.
5. If using a footswitch, connect a monopolar footcontrol adaptor (A1210A) to the Monopolar 1 receptacle and connect a Monopolar footswitch into the receptacle located furthest left on the rear of the unit.
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 Medical Corporation
PRELIMINARY 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® Surgi-Center│PRO 3-3
3-4 Bovie Medical Corporation
USING THE AARON® SURGI-CENTER
│PRO
This section contains the following procedures:
Inspecting the Generator and Accessories
Setup Safety
Confirming Modes
Setting Up for Surgery
Preparing for Monopolar Surgery
Preparing for Bipolar Surgery
Setting and Recalling Memory Presets
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® Surgi-Center│PRO 4-1
INSPECTING THE GENERATOR AND ACCESSORIES
Before each use of the Aaron® Surgi-Center │PRO, 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 procedure 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.
Danger: Fire / Explosion Hazard - Do not use the Aaron® Surgi-Center│PRO 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.
To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
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.
Active cord removal during activation could result in a shock to the operator at the generator connector plug interface should activation occur by footswitch.
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.
No modification of this equipment is allowed.
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.
To avoid incompatibility and unsafe operation, use suitable cables, accessories, active and neutral electrodes, including values for the highest allowed H.F. peak voltage.
Connected accessories need be rated for at least the maximum peak output voltage of the H.F.
generator set at the intended output control setting in the intended operating mode.
The entire area of neutral electrode should be reliably attached to patient's body and as close to operating field as possible.
4-2 Bovie Medical Corporation
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. Bovie Medical
Corporation recommends the use of split return electrodes and Bovie® 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.
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.
CONFIRMING MODES
Confirm that you can select each mode and adjust the power up and down for each mode including: Cut 1, Cut II, Blend 1, Blend 2,
Blend 3, Blend 4, Pinpoint Coag, Spray Coag, Gentle Coag, Macro Bipolar, Micro Bipolar, and Standard Bipolar.
Checking Bipolar Mode (with bipolar footswitch)
1. Plug in the Bipolar footswitch (BV1254B).
2. Press the pedal on the Bipolar footswitch. Verify that the Bipolar mode activation indicator illuminates and that the system
User ’s Guide • Aaron® Surgi-Center│PRO 4-3
generates the Bipolar activation tone and LED under Bipolar display illuminates (blue).
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 (BV1253B).
2. Connect a solid return electrode to the return electrode receptacle. Verify that the green solid return electrode indicator illuminates.
3. Plug a monopolar footswitching accessory into the Monopolar 1 receptacle.
4. 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 and LED under Cut display illuminates (yellow).
5. While activating the Cut mode, rotate the volume control over the full range to verify that the sound is audible throughout the range.
6. 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.
7. While activating the Coag mode, rotate the volume control over the full range to verify that the sound is audible throughout the range.
NOTICES:
Two handpieces can be connected to the unit at once. Only one handpiece can be activated at a time (first come, first serve feature) in the Cut modes, Pinpoint mode and Gentle Coag mode.
Dual activation is available only in the Spray mode.
Checking Monopolar Mode (with handpiece)
1. Connect a handswitching handpiece to the Monopolar 1 and Monopolar 2 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 for Monopolar 1 and Monopolar 2. Verify that each control causes the correct indicator and tone to sound.
SETTING UP FOR SURGERY
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:
• Visual indicators and displays on the front panel illuminate (except Ammeter).
4-4 Bovie Medical Corporation
• 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; a Bipolar mode is selected.
• Each display shows a power setting. The unit automatically powers up to the last successfully activated mode and power setting.
• The Patient Return Electrode Alert Indicator illuminates red.
If the self-test is not successful, an alert tone sounds. An error code will be displayed, and 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.
PREPARING FOR MONOPOLAR SURGERY
Monopolar surgery requires a return electrode.
Applying the Return Electrode
To maximize patient safety, Bovie Medical Corporation recommends using a split return electrode and a Bovie® generator with a contact quality monitoring system (Bovie NEM™).
NOTICE:
The Bovie NEM™ system recommends that you use a split return electrode.
Before activation, pad placement and visual verification of the split return electrode (split pad) indicator on the front panel is recommended. After connecting the split pad to the generator and placing the split pad securely to the patient, give the unit 3 seconds to recognize the split pad. The split pad indicator will illuminate green. If the split pad and cord are attached to the generator without secure contact to the patient, the alert indicator will illuminate red.
Refer to the return electrode 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 impedance at the contact between the electrode and the patient.
Selecting and Adjusting the Power
1. Select mode for cutting (Cut I, Cut II, Blend).
2. Select the desired power settings for Cutting. Adjustment is preformed by pressing the up or down buttons to the right of the Cut power display.
3. If using Blend, adjust the Blend setting to the desired amount of hemostasis (Blend Level 1-4). Adjustment is preformed by pressing the up or down buttons to the right of the Blend setting indicator. A higher Blend number will increase tissue hemostasis effect.
4. Select the mode of operation for Coagulation (Pinpoint, Spray or Gentle).
5. Select the desired power setting for Coagulation. Adjustment is preformed by pressing the up or down buttons to the right of the
Coag display.
User ’s Guide • Aaron® Surgi-Center│PRO 4-5
Connecting Accessories
1. Connect a 3-pin monopolar device into one of the monopolar receptacles on the front of the unit.
If you are using… Connect it to…
Standard 3-pin handswitching pencil
Footswitching pencil
Monopolar handswitching receptacle 1 or 2
Monopolar footswitching receptacle 1 (via A1210A)
If footswitching control capabilities are preferred, connect the Bovie® monopolar footswitch (BV-1253) to the appropriate monopolar footswitch connecting socket on the rear of the unit.
To activate the Monopolar mode, depress the Cut (yellow) or Coag (blue) button on the monopolar handpiece or the Cut (yellow) or
Coag (blue) pedal on the monopolar footswitch.
Blend Controls
Blend settings can be adjusted to a desired amount of hemostasis (Blend Level 1-4). Ascending illuminated bars indicate increased hemostasis levels. Increase and decrease the level of Blend by pressing the Blend level control arrowed buttons.
NOTICE:
There are 4 levels of blend available in the Blend Mode.
PREPARING FOR BIPOLAR SURGERY
1. Connect a Bipolar cable to the Bipolar receptacle on the front of the unit.
2. Connect a Bipolar instrument to the bipolar cable.
3. Connect the bipolar footswitch to the appropriate bipolar footswitch connecting socket located on the rear of the unit.
4. Select the mode of operation for Bipolar, either Macro, Micro, or Standard .
5. Select the desired power setting for Bipolar.
6. To activate the Bipolar mode, depress the pedal on the bipolar footswitch.
SETTING AND RECALLING RF MEMORY PRESETS
The Aaron® Surgi-Center │PRO incorporates 10 user-defined RF memory preset settings for easy recall of frequently used settings in all three modes.
RF Memory
The Memory feature allows the Aaron® Surgi-Center
│PRO (unit) to display the last activated mode and power setting of the handpiece or footswitch, the unit will operate in that particular mode and power setting. Presets (0-9) save one Cut mode, one Coag mode, and one Bipolar mode and selected power settings.
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, but not saved. User must depress the Set Button until number blinks.
All activated settings must be saved as a Preset to be available at startup as a Preset set selection (0 through 9) when using the unit.
4-6 Bovie Medical Corporation
Memory Function Overview
• The unit powers up with the last selected preset (0-9). Number, not the Preset mode and power setting.
• Mode (Cut, Coag and Bipolar) membrane switches are disabled during activation.
• Blend level 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 increments. Refer to the following
table for power increments.
POWER SETTINGS INCREMENTS Example
1-50 Watts
50-100 Watts
100-200 Watts
1 Watts
2 Watts
5 Watts
While activated, the Cut 1 power output of 30 watts can be adjusted 4 increments down to 26 watts or 4 increments up to 34 watts.
• 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, Spray or Gentle) and power setting, and one
Bipolar (Macro, Micro, or Standard) power setting. When storing, only the information displayed in the display windows will be saved to the unit’s memory.
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 selector membrane level (Cut, Coag, and Bipolar).
If presetting the Blend mode, select the desired level of hemostasis (Blend level 1-4) by pressing the Blend level control button.
Select the desired mode power (Cut, Coag, and Bipolar) to be stored by using the power output up and down membrane switches of a mode.
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 and the small red dot will stop flashing.
To recall a Preset (0-9), repeatedly press the Recall button to toggle through all of the presets until desired preset is acquired.
NOTICES:
The Aaron® Surgi-Center│PRO incorporates 10 factory-set presets that are all set to zero and can be reset to your preferred RF 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, Spray or Gentle) and power setting, and Bipolar (Macro,
Micro, or Standard) power setting. When storing, only the information displayed in the display windows will be saved to the unit’s memory.
User ’s Guide • Aaron® Surgi-Center│PRO 4-7
Memory Feature (Last Selected RF Preset)
The Memory feature allows the unit to display the last activated mode and when the generator is turned on.
NOTICE:
To have a setting selection available at startup as one of the 10 user-defined presets, the adjustment to the mode and/or power settings must be saved by pressing and holding the Set button on the Preset display panel.
ACTIVATING THE UNIT
NOTICE:
Review
Activation Safety
on page 13 of this section before activating the unit. When you turn on your unit remember the following feature:
The Aaron® Surgi-Center│PRO will power up to the modes and settings displayed when the unit was last activated. For example, if you set Cut I mode at 50 watts and activate the unit, then turn the unit off, it will automatically return to Cut I mode at 50 watts when you turn it on again.
Similarly, if you set Pinpoint mode at 40 watts and activate the unit before you turn it off, it will return to Pinpoint mode at 40 watts when you turn it on again.
1. Monopolar Cut - select the mode of operation for Cut: Cut I, Cut II, or Blend (level 1-4) 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 level by pressing the up and down buttons to the right of the Blend mode level indicator.
3. Monopolar Coag - select the mode of operation for coagulation: Pinpoint, Spray or Gentle, then select the coagulation power settings by pressing the up and down buttons to the right of the Coag power output display.
4. Bipolar - Select the Mode of Operation for Bipolar output (Macro, Micro, or Standard), 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.
6. After use, turn off the generator by pressing the power switch OFF (O).
7. Unplug the generator power cord from the grounded 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® Surgi-Center│PRO 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.
4-8 Bovie Medical Corporation
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.
Avoid using power settings that would exceed the highest maximum voltage that is acceptable for each accessory. Choose only accessories that will withstand each mode and power setting.
To avoid incompatibility and unsafe operation, use suitable cables, accessories, active and neutral electrodes, including values for the highest allowed H.F. peak voltage.
Some accessories have multiple buttons that can deliver different surgical effects. Verify accessory features and proper mode settings prior to activation.
Connected accessories need be rated for at least the maximum peak output voltage of the H.F.
generator set at the intended output control setting in the intended operating mode.
Associated equipment and accessories used must be rated to withstand the combination of the maximum Vpeak rating and Crest Factor for the following RF modes: Blend, Pinpoint and Spray.
The output power selected should be as low as possible for the intended purpose. Certain devices or accessories may present a safety hazard at low power settings.
Apparent low output or failure of the IDS-210 RF to function correctly at the normal operating settings may indicate faulty application of the neutral electrode or poor contact in its connections. In this case, the application of the neutral electrode and its connections should be checked before selecting a higher output power.
When using Cut mode, associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 1000 Vpeak max.
When using Blend mode, associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 1870 Vpeak max.
When using Coagulation mode, associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 4000 Vpeak max.
When using Bipolar mode, associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 600 Vpeak max.
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.
The entire area of neutral electrode should be reliably attached to patient's body and as close to operating field as possible.
Minor neuromuscular stimulation is possible when arcs between the ACTIVE ELECTRODE and tissue occur. The generator has been designed to minimize the possibility of neuromuscular stimulation.
Accessories must be connected to the proper receptacle type. In particular, Bipolar accessories must be connected to the Bipolar Instrument output jack only. Improper connection may result in unsafe generator power output.
The use of flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and oxygen should be avoided if a surgical procedure is carried out in the region of the thorax or the head, unless these agents are sucked away.
Non-flammable agents should be used for cleaning and disinfection wherever possible.
User ’s Guide • Aaron® Surgi-Center│PRO 4-9
4-10
Flammable agents used for cleaning or disinfecting, or as solvents of adhesives, should be allowed to evaporate before the application if HF surgery. There is a risk of pooling flammable solutions under the patient or in body depressions such as the umbilicus, and in body cavities such as the vagina. Any fluids pooled in these areas should be mopped up before HF surgical equipment is used. Attention should be called to the danger of ignition of endogenous gases.
Some materials, for example cotton, wool and gauze, when saturated with oxygen may be ignited by sparks produced in Normal Use of the HF surgical equipment.
The generator is equipped with a return electrode sensing and contact quality monitoring system
(NEM), which monitors the quality of the patient return electrode connection. When a correctly functioning single plate return electrode is connected to the generator, the NEM (contact quality monitor) verifies the connections between the generator and the single return electrode. It DOES
NOT verify that a single return electrode is in contact with the patient. When using a split return electrode, the NEM (contact quality monitor) confirms the total resistance is within the preset safety range. Proper application and visual inspection of the patient return electrode is required for safe operation.
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.
To avoid the possibility of a burn to the patient, when using a split pad do not activate the unit if the solid pad indicator is illuminated green or the red alert indicator remains illuminated red. This could indicate improper pad placement or a faulty NEM (contact quality monitor) circuit.
Remove any 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.
Bovie Medical Corporation
MAINTAINING THE AARON® SURGI-CENTER
│PRO
This section covers the following topics:
●●
Cleaning
●●
Periodic Inspection
●●
Fuse Replacement
User ’s Guide • Aaron® Surgi-Center│PRO 5-1
Bovie Medical Corporation 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 Bovie IDS-210™ 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 (T6.3AL250V) 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 Medical Corporation
TROUBLESHOOTING
This section includes Error Code Descriptions and actions to take to resolve them.
User ’s Guide • Aaron® Surgi-Center│PRO 6-1
The Aaron® Surgi-Center
│PRO 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. Power off unit and call 727-384-2323.
NOTICE:
If the unit does not power on and nothing is displayed in the Bipolar display, check fuses as described in Section 5 of this guide.
SYSTEM FAULT CODE MESSAGES
Fault messages (F) indicate improper unit setup or faulty accessories.
Fault Code Description
F1
F2
F3
F4
F5
Cut button on handpiece 1 is depressed during power up.
Coag button on handpiece 1 is depressed during power up.
Cut button on handpiece 2 is depressed during power up.
Coag button on handpiece 2 is depressed during power up.
Cut pedal on monopolar footswitch is depressed during power up.
F6
F7
F8
F9
Recommended Action
Coag pedal on monopolar footswitch is depressed during power up.
Bipolar pedal on bipolar footswitch is depressed during power up.
Bipolar activation button is depressed during power up.
Simultaneous activation from a footswitch or handpiece or any combination. This does not
apply to activation of the spray mode.
1. If the fault code appears, disconnect all accessories.
Turn off, then turn on the generator again.
2. If the problem persists, replace the handpiece or footswitch
and repeat the restart.
3. If the fault code reappears, record the number and contact
Bovie
® customer service at 727-384-2323.
F10
Activation request of a monopolar or bipolar footswitch when no footswitch connection or
Bovie® approved footswitch is detected.
F11
Activation request of a monopolar handpiece
1 when no monopolar footcontrolled handpiece connected to the monopolar
handpiece connector 1.
6-2 Bovie Medical Corporation
SYSTEM FATAL ERROR MESSAGES
Error messages (E) indicate internal problems with the unit.
Error Code Description
E1
Output Current out of Specification,
Digital Check
Recommended Action
E4
E5
DC Voltage Error
Temperature Sense Error 1
E10
E11
E12
E6
E7
E8
E9
Temperature Sense Error 2
NEM / Autobipolar Error
NEM Calibration Error
A/D Error
Watch Dog Error
Relay Board Cable Sense Error
Dosage Error
1. Turn the unit off (for Temperature Errors, let unit cool for 20 minutes).
2. Turn the unit on.
3. If the error code reappears, record the number and contact
Bovie
® customer service at 727-384-2323.
User ’s Guide • Aaron® Surgi-Center│PRO 6-3
6-4 Bovie Medical Corporation
REPAIR POLICY AND PROCEDURES
Refer to this section for information on:
●●
Responsibility of the Manufacturer
●●
Returning the Generator for Service
User ’s Guide • Aaron® Surgi-Center│PRO 7-1
RESPONSIBILITY OF THE MANUFACTURER
Bovie® 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 Corporation performed assembly operation, readjustments, modifications, or repairs.
• The electrical installation of the relevant room complies with local codes and regulatory requirements, such as IEC and BSI.
• Equipment use is in accordance with the Bovie Medical Corporation instructions for use.
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 Corporation. Contact your Bovie Medical Corporation representative for return instructions.
For warranty information, refer to Appendix B - Warranty.
RETURNING THE GENERATOR FOR SERVICE
Before you return the generator, call your Bovie Medical Corporation representative for assistance. If instructed to send the generator to Bovie Medical Corporation, 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® Return Goods Authorization Number on the outside of the box and ship directly to Bovie Medical Corporation.
Step 1 – Obtain a Returned Goods Authorization Number
Call the Bovie Medical Corporation 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 / Serial 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 Corporation Service Center.
7-2 Bovie Medical Corporation
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® Surgi-Center│PRO A-1
PERFORMANCE CHARACTERISTICS
Input Power
Input Voltage 100-240V~ ± 10%
Mains line frequency range (nominal): 50 – 60 Hz
Power consumption:
Fuses (two):
560 VA
6.3 A (slow blow)
Duty Cycle
Under maximum power settings and rated load conditions (Cut I, 200 watt @ 300 ohm load), the generator is suitable for activation times of 10 seconds ON followed by 30 seconds OFF for 30 minutes.
The internal temperature of the unit is continuously monitored. If the temperature rises above 75
0
C, the alert will sound and output power will be deactivated.
Dimensions and Weight
Width
37.5 cm (14.75 in.)
Height
16.5 cm (6.5 in.)
Depth
Weight
46 cm (18.1 in.)
< 9.07 kg (< 20 lbs)
Operating Parameters
Ambient temperature range
Relative humidity
Atmospheric pressure
Warm-up time
10° to 40° C
30% to 75%, non-condensing
70kPa to 106kPa
If transported or stored at temperatures outside the operating temperature range, allow one hour for the generator to reach room temperature before use.
Transport
Ambient temperature range
Relative humidity
Atmospheric pressure
-40˚ to +70˚ C
10% to 100%, including condensation
50kPa to 106kPa
Storage
Ambient temperature range
Relative humidity
Atmospheric pressure
10˚ to 30˚ C
30% to 75%, non-condensing
50kPa to 106kPa
The device should be stored and used in a room temperature of approximately 77 0 F/25 0 C.
A-2 Bovie Medical Corporation
Audio Volume
The audio levels stated below are for activation tones (cut, coag, and bipolar) and alert tones (return electrode and system alerts) at a distance of one meter. Alert tones meet the requirements for IEC 60601-2-2.
Activation Tone
Volume (adjustable)
Frequency
Duration
≥ 40 dB
All Cut Modes: 610 Hz ± 10 Hz
All Coagulation Modes: 910 Hz ± 10 Hz
Simultaneous Spray Mode: 1667 Hz ± 50 Hz
All Bipolar Modes: 910 Hz ± 10 Hz
Continuous while the generator is activated
Alert Tone
Volume (not adjustable)
> 65 dB
Fault Tone
Volume (not adjustable)
Audio Fault Tone
Ammeter Tone & Volume
> 65 dB
2.4 kHz 450 milliseconds / 1.2 kHz 450 milliseconds
Current Up Tone = 1667Hz +/- 50Hz for 100ms +/- 10ms
Current Down Tone = 610Hz +/- 10 Hz for 100ms +/- 10m
Return Electrode Sensing
The system presents audible and visible alerts when it senses no return electrode.
Solid
Split
Trip resistance: 0 Ω to 8 Ω ± 1 Ω
Continuous measurement:
Once the system establishes the solid return electrode resistance, an
increase to 20 Ω - 25 Ω in resistance will cause an alert. When the
alert condition exists, the system deactivates output power.
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 alert. When the alert
condition exists, the system deactivates output power.
User ’s Guide • Aaron® Surgi-Center│PRO A-3
High Frequency (RF) Leakage Current
Bipolar Micro, Macro leakage current
Bipolar Standard leakage current
Monopolar RF leakage current
< 63 mA
rms
< 50 mA
rms
< 150 mA
rms
Operating Conditions
RF energy is generated and passed through an interconnecting cable to an accessory where the energy is delivered to cut, coagulate and ablate tissue.
STANDARDS AND IEC CLASSIFICATIONS
Class I Equipment (IEC 60601-1)
Equipment protection against electric shock by (Earthed) additional protection to basic insulation through means of connecting exposed conductive parts to the protective Earth in the fixed wiring of the installation.
Type CF Equipment (IEC 60601-1) / Defibrillator Proof
The Aaron® Surgi-Center
│PRO 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.
Spill Resistance (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® Surgi-Center
│PRO, 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® Surgi-Center
│PRO 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® Surgi-Center
│PRO operates in a safe manner when the transfer is made between line AC and an emergency generator voltage source.
A-4 Bovie Medical Corporation
Mode
Cut I
Cut II
Blend
(1)
Blend
(2)
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.
Max Power Rated Load Output Frequency Repetition Rate
200 W 300 Ω 490 kHz ± 4.9 kHz N/A
200 W 300 Ω 490 kHz ± 4.9 kHz N/A
200 W 300 Ω 490 kHz ± 4.9 kHz 30 kHz ± 5 kHz
200 W 300 Ω
Duty Cycle
N/A
N/A
75% duty cycle
Vpeak max
Crest
Factor*
(Rated Load)
1000V 1.7 ± 20%
750V
1320V
1.7 ± 20%
1.8 ± 20%
490 kHz ± 4.9 kHz 30 kHz ± 5 kHz
62.5% duty cycle
1475V 2.0 ± 20%
Blend
(3)
Blend
(4)
200 W
200 W
300 Ω
300 Ω
490 kHz ± 4.9 kHz 30 kHz ± 5 kHz
50% duty cycle
1650V 2.2 ± 20%
490 kHz ± 4.9 kHz 30 kHz ± 5 kHz
37.5% duty cycle
1870V 2.4 ± 20%
Pinpoint Coag 120 W 500 Ω 490 kHz ± 4.9 kHz 30 kHz ± 5 kHz
Spray Coag
Gentle Coag
Macro Bipolar
120 W
120 W
80 W
500 Ω
125 Ω
100 Ω
350 to 450 kHz
490 kHz ± 4.9 kHz
490 kHz ± 4.9 kHz
20 to 45 kHz
N/A
N/A
Micro Bipolar 80 W 100 Ω 490 kHz ± 4.9 kHz N/A
Standard Bipolar 50 W 50 Ω 490 kHz ± 4.9 kHz N/A
• an indication of a waveform's ability to coagulate bleeders without a cutting effect.
25% duty cycle
5.9 to 14.2% duty cycle
N/A
N/A
N/A
N/A
1800V 3.1 ± 20%
4000V 6.0 ± 20%
450V 1.6 ± 20%
600V 1.5 ± 20%
500V 1.5 ± 20%
250V 1.5 ± 20%
EMC COMPLIANCE
Special precautions should be taken regarding the Aaron® Surgi-Center
│PRO. 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® 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
Aaron® Surgi-Center
│PRO The Aaron® Surgi-Center│PRO and its accessories are not suitable for interconnection with other equipment.
User ’s Guide • Aaron® Surgi-Center│PRO A-5
Portable and mobile RF communications equipment can affect Medical Electrical Equipment. The Aaron® Surgi-Center
│PRO should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the Aaron® Surgi-
Center
│PRO should be observed to verify normal operation in the configuration in which it will be used.
Recommended separation distances between portable and mobile RF communications equipment and the Aaron® Surgi-Center
│PRO
The Aaron® Surgi-Center
│PRO is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Aaron® Surgi-
Center
│PRO can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Aaron®
Surgi-Center
│PRO 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
150 kHz to 80 MHz d =
[
3.5
]
√
P
V
1
0.12
0.38
1.2
3.8
12
80 MHz to 800 MHz d =
[
3.5
]
√
P
E
1
0.12
0.38
1.2
3.8
12
800 MHz to 2.5 GHz d =
[
7
]
√
P
E
1
0.23
0.73
2.3
7.3
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 Aaron® Surgi-Center
│PRO is intended for use in the electromagnetic environment listed below. The customer or the user of the Aaron® Surgi-Center
│PRO should assure that is is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF Emissions CISPR 11 Group 2
The Aaron® Surgi-Center
│PRO must emit electromagnetic energy in order to perform its intended function.
Nearby electronic equipment may be affected.
RF Emissions CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/flicker emissions IEC 61000-3-3
Class A
Class A
Complies
The Aaron® Surgi-Center
│PRO 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.
A-6 Bovie Medical Corporation
Guidance and manufacturer’s declaration – electromagnetic immunity
The Aaron® Surgi-Center
│PRO is intended for use in the electromagnetic environment listed below.
The customer or
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
Surge IEC 61000-4-5
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV differential mode
±2 kV common mode
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV differential mode
±2 kV common
Mains power quality should be that of a typical commercial or hospital environment.
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 % Ut
(<95 % dip in U
t
) for 0.5 cycle
<5 % Ut
(<95 % dip in U
t
) for 0.5 cycle
<40 % Ut
(<60 % dip in U
t
) for 5 cycles
<40 % Ut
(<60 % dip in U
t
) for 5 cycles
70 % Ut
(<30 % dip in U
t
) for 25 cycles
70 % Ut
(<30 % dip in U
t
) for 25 cycles
<5 % Ut
(>95 % dip in U
t
) for 5 sec
<5 % Ut
(>95 % dip in U
t
) for 5 sec
Mains power quality should be that of a typical commercial or hospital environment. If the user of the Aaron® Surgi-
Center
│PRO requires continued operation during power mains interruptions, it is recommended that the Aaron®
Surgi-Center
│PRO 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
Ut is the a.c. mains voltage prior to application of the test level.
User ’s Guide • Aaron® Surgi-Center│PRO A-7
A-8
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
Portable and mobile RF communications equipment should be used no closer to any part of the Aaron® Surgi-Center
│PRO, 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
V
1 d =
[
3.5
]
√
P
E
1
80 MHz to 800 MHz
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m d =
[
7
]
√
P
E
1
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 Aaron® Surgi-Center
│PRO is used exceeds the applicable RF compliance level above, the Aaron® Surgi-Center
│PRO should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
Aaron® Surgi-Center
│PRO .
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V
1
] V/m.
Bovie Medical Corporation
OUTPUT POWER CURVES
Figures A–1 through A–9 llustrate specific output power delivered to a range of load resistances for each mode.
Figure A – 1 Output power versus impedance for CUT I mode
Figure A – 2 Output power versus impedance for CUT II mode
User ’s Guide • Aaron® Surgi-Center│PRO A-9
Figure A – 3 Output power versus impedance for BLEND mode (1, 2, 3, 4)
Figure A – 4 Output power versus impedance for PINPOINT COAGULATION mode
A-10 Bovie Medical Corporation
Figure A – 5 Output power versus impedance for SPRAY COAGULATION mode
Figure A – 6 Output power versus impedance for GENTLE COAGULATION mode
User ’s Guide • Aaron® Surgi-Center│PRO A-11
Figure A – 7 Output power versus impedance for MACRO BIPOLAR mode
Figure A – 8 Output power versus impedance for MICRO BIPOLARmode
A-12 Bovie Medical Corporation
Figure A – 9 Output power versus impedance for STANDARD BIPOLAR mode
User ’s Guide • Aaron® Surgi-Center│PRO A-13
A-14 Bovie Medical Corporation
WARRANTY
Bovie Medical Corporation, 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 Corporation’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 Corporation’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
Corporation’s factory in a way so as, in Bovie Medical Corporation’s judgment, to affect its stability or reliability, or which has been subjected to misuse, neglect, or accident.
The warranty periods for Bovie Medical Corporation products are as follows:
• Electrosurgical Generators: Four 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
• Handpiece: Only as stated on packaging
User ’s Guide • Aaron® Surgi-Center│PRO B-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 Medical Corporation.
Bovie Medical Corporation 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 Corporation’s products.
Notwithstanding any other provision herein or in any other document or communication, Bovie Medical Corporation’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 Corporation to the customer.
Bovie Medical Corporation 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 Corporation, 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.
B-2 Bovie Medical Corporation
MC-55-232-001 Rev. 0
2014-01-07
Bovie Medical Corporation
5115 Ulmerton Road
Clearwater, FL 33760 USA
U.S. Phone 1-800-537-2790 • Fax 1-800-323-1640
Int’l. Phone +1-727-384-2323 • Fax +1-727-347-9144 www.boviemed.com • [email protected]
Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands

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Key features
- Two Cut Modes
- Four Levels of Blend
- Three Coagulation Modes
- Return electrode sensing and contact quality monitoring
- Three Bipolar Modes
- Presets
- FDFSTM (Fast Digital Feedback System)