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Aaron 3250 User Guide - Bovie Medical Corporation

1. e Aaron 3250 Electrosurgical Generato me Gwe ELECTROSURGICAL GENERATOR a Presets USER S GUIDE ee e ELECTROSURGICAL GENERATOR Presets a Dew gt Coagulation or 7 ad 7 Cut cu O Fuiguration V E 1 Select Set a Footswitch Indicator pen Return Electrode Si o o Ap o Power F sp Q am A Monopolar Bipolar Foot Control Monopolar Return Electrode K i oo EB User s Guide Aaron 3250 Bovie Medica 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 3250 only Additional technical information is available in the Aaron 3250 Service Guide Equipment Covered in this Manual Aaron 3250 Reference No A3250 For Information Contact Bovie Medical Corporation 5115 Ulmerton Road Clearwater FL 33760 4004 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 sales boviemed com 2013 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 55 104 001 Rev 4 CONVENTIONS USED IN THIS GUIDE Indicates a potentially hazardous situation which if not avoided
2. 200 W 100 W Figure A 6 Output power vs impedance for Blend Max mode Blend Maximum 225 200 b pa et H um N um n Output Power Watts y un o 0 500 1000 i500 2000 Load Resistance Ohms 200W 100 W User s Guide Aaron 3250 A 11 Figure A 7 Output power vs impedance for Pinpoint mode Output Power Watts 140 Va H a ta a o Pinpoint Coagulation 500 1000 1500 2000 Load Resistance Ohms Figure A 8 Output power vs impedance for Spray mode Output Power Watts Lal P un On st co w o O O o o a a fy a Spray Coag 500 1000 1500 2000 Load Resistance Ohms 80 W 40 W Bovie Medical Corporation Figure A 9 Output power vs impedance for Bipolar mode Bipolar d DD 8 gt CG G 60 N o Output Power Watts hs G 3 1000 Load Resistance Ohms 80 W 40 W User s Guide Aaron 3250 Bovie Medical Corporation WARRANTY Bovie Medical Corporation warrants each product manufactured by it to be free from defects in material and work manship 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
3. Otherwise inaccurate power outputs may result The instrument receptacles on this generator are designed to accept only one instrument at a time Do not attempt to connect more than one instrument at a time into a given receptacle Doing so will cause simultaneous activation of the instruments Failure of the high frequency electrosurgical equipment could result in an unintended increase of output power Do not use electrosurgical equipment unless properly trained to use it in the specific procedure being undertaken Use by physicians without such training has resulted in serious unintended patient injury including bowel perforation and unintended irreversible tissue necrosis For surgical procedures where the high frequency current could flow through parts of the body having a relatively small cross sectional area the use of bipolar techniques may be desirable to avoid unwanted coagulation If the patient has an implantable cardioverter defibrillator ICD contact the ICD manufacturer for instructions before performing an electrosurgical procedure Electrosurgery may cause multiple activation of ICDs In some circumstances potential exists for alternate site burns at points of skin contact e g between the arm and the side of the body This occurs when electrosurgical current seeks a path to the patient return electrode that includes the skin to skin contact point Current passing through small skin to skin contact
4. W 0 12 0 38 1 2 3 8 12 For transmitters rated at a maximum output power not listed above the recommended separation distance din 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 3250 is intended for use in the electromagnetic environment listed below The customer or the user of the Aaron 3250 should assure that is used in such an environment Emissions test Compliance Electromagnetic environment guidance The Aaron 3250 must emit electromagnetic energy in order RF Emissions CISPR 11 to perform its intended function Nearby electronic equipment may be affected RF Emissions CISPR 11 Class A The Aaron 3250 is suitable for use in all establishments other Harmonic emissions than domestic and those directly IEC 61000 3 2 connected to the public low voltage power supply net work that supplies buildings used Complies in domestic purposes Voltage fluctuations flicker emissions
5. Bovie Medical is responsible for the safety reliability and performance of the generator only under the following circumstances e The user has followed the Installation and Setup Procedures in this User s Guide Persons authorized by Bovie Medical performed assembly operation readjustments modifications or repairs e The electrical installation of the relevant room complies with local codes and regulatory requirements Equipment use is in accordance with the Bovie Medical instructions for use For warranty information refer to Appendix B Warranty RETURNING THE GENERATOR FOR SERVICE Before you return the generator call your Bovie Medical representative for assistance If instructed to send the genera tor to Bovie Medical first obtain a Returned Goods Authorization Number Then clean the Generator and package securely to ensure proper protection of the unit So as to aid in the processing of the unit please be sure to include a reference to the Bovie Return Goods Authorization Number on the outside of the box and ship directly to Bovie Medical Step 1 Obtain a Returned Goods Authorization Number Call the Bovie Medical Customer Service Center to obtain a Returned Goods Authorization Number Have the following information ready when you call Hospital clinic name customer number Description of the problem Telephone number fax number e Type of repair to be done Department address city state and zip code P
6. 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 relia bility or which has been subjected to misuse neglect or accident The warranty periods for Bovie Medical Corporation products are as follows e Electrosurgical Generators Two years from date of shipment e Mounting Fixtures all models Two years from date of shipment Footswitches all models Ninety days from date of shipment Patient Return Electrodes Shelf life only as stated on packaging Sterile Single Use Accessories Only as stated on packaging User s Guide e Aaron 3250 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 agreemen
7. IEC 61000 3 3 Bovie Medical Corporation Guidance and manufacturer s declaration electromagnetic immunity The Aaron 3250TMis intended for use in the electromagnetic environment listed below The customer or the user of the Aaron 3250 should assure that is used in such an environment Immunity test SE Compliance level Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrostatic discharge 6 kV contact 6 kV contact ESD IEC 61000 4 2 8 kV air 8 KV air Electrical fast N fos PRE EEE tor power Mains power quality should be supply lines supply lines i that of a typical commercial or transient burst 1 KV for 1 KV for at of a typical commercial o IEC 61000 4 4 hospital environment GC input output lines input output lines pe differential 1 KV differential Mains power quality should be mode Surge IEC 61000 4 5 mode that of a typical commercial or 2 kV common 2 kV common hospital environment mode lt 5 Uy lt 5 U lt 95 dip in U lt 95 dip in U Mains power quality should be for 0 5 cycle for 0 5 cycle that of a typical commercial or tee lt 40 U lt 40 U hospital environment If the user lee lt 60 dip in U lt 60 dip in U of the Aaron 3250 requires interruptions and voltage Je 5 cycles for 5 cycles continued opera
8. 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 5 to 10 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 Memory The unit automatically powers up to the last selected preset settings Isolated RF output This minimizes the potential of alternate site burns 1 2 Bovie Medica Corporation Standard connectors These connectors accept the latest monopolar and bipolar instruments Refer to Section 2 Controls Indicators and Receptacles to learn more e Self diagnostics These diagnostics continually monitor the unit to ensure proper performance COMPONENTS AND ACCESSORIES You should receive the following components with your generator e Aaron 3250 e Hospital grade power cord 110 VAC and 220 VAC e User s Guide User s Guide Aaron 32507 SAFETY The safe and effective use of electrosurgery depends to a large degree on factors solely under the control of the opera tor There is no substitute for a properly trained and vigilant medical staff It is important that they read under
9. O number e Model number Step 2 Clean the Generator 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 hos pital phone number etc listed in Step 1 Obtain a Returned Goods Authorization Number B Be sure the generator is completely dry before you pack it for shipment Although the preference is to have the Generator repackaged using its original packaging Bovie understands that this may not always be possible If necessary contact Customer Service for the proper packaging to ship the unit Please be sure to include a reference of the Bovie Return Goods Authorization Number on the outside of the box container C Ship the generator prepaid to the address given to you by the Bovie Medical Service Center 7 2 Bovie Medica Cor
10. could result in death or serious injury CAUTION Indicates a hazardous situation which if not avoided may result in minor or moderate injury NOTICE Indicates an operating tip a maintenance suggestion or a hazard that may result in product damage User s Guide Aaron 3250 iii TABLE OF CONTENTS Equipment Covered in this Manual iii For Information Contacts pd iii Conventions Used in this Guide iii Introducing the Aaron 32507 n seseeresveseesesvesvevenveneesenveneesenvenveseesenveseesenvenvesenvesvesenvenvesensenn 1 1 KE Ag EEE ar DAE T rt nt ANA 1 2 Components and Accessories 1 3 Safety EE 1 4 Controls Indicators and Receptacles ss 2 1 Front Panel gereest A inet tee 2 2 Symbols on the Front Panel teg deet a 2 3 NET E 2 4 Cutand Blend Controls minas 2 5 Coag Mel 2 6 ee EE 2 7 te 010 EE EE AEE TE 2 8 Power Switch and Deceptachkes ENEE 2 9 Rear EE 2 10 Symbols on the Rear Panel ss 2 10 Getting Started E 3 1 Initial E TEE 3 2 EVE Te RE A O 3 2 Function CHECKS E 3 2 Setting Up the DIE 3 2 Checking the Return Electrode Alarm 3 2 Confirming EE 3 3 Checking Bipolar Mode with bipolar footswitch AA 3 3 Checking Monopolar Mode with monopolar footswitch AA 3 3 Checking Monopolar Mode with handswitch E 3 3 Performance Chetksu ann tracts Ae A ad 3 3 Using the ETGEN 4 1 Inspecting the Generator and Accessories AEN 4 2 SUE 4 2 Setting EEE anni ntm nine 4 3 Preparing for Monopolar S
11. higher the current flow and the longer the current is applied the greater the possibility of unintended thermal damage to tissue especially during use on small structures 1 4 Bovie Medica Corporation Use electrosurgery with caution in the presence of internal or external devices such as pacemak ers or pulse generators Interference produced by the use of electrosurgical devices can cause devices such as pacemakers to enter an asynchronous mode or can block the pacemaker effect entirely Consult the device manufacturer or hospital Cardiology Department for further information when use of electrosurgical appliances is planned for patients with cardiac pacemakers or other implantable devices If the patient has an Implantable Cardioverter Defibrillator ICD contact the ICD manufacturer for instructions before performing an electrosurgical procedure Electrosurgery may cause multiple activation of ICDs Do not use electrosurgical equipment unless properly trained to use it in the specific procedure being undertaken Use by physicians without such training has resulted in serious unintended patient injury including bowel perforation and unintended irreversible tissue necrosis For surgical procedures where the high frequency current could flow through parts of the body having a relatively small cross sectional area the use of bipolar techniques may be desirable to avoid unwanted coagulation In some circumstances potenti
12. in the event Bipolar Power Control Buttons of an error Increases or decreases the Bipolar power output in increments of 1 to 5 watts Bipolar Activation Indicator 3 gt Bipolar llluminates when Bipolar mode is activated User s Guide Aaron 3250 2 7 INDICATORS Figure 2 6 Indicators for power return electrodes and footswitch control Monopolar Footswitch Indicator Bipolar Footswitch Indicator Illuminates when monopolar Illuminates when bipolar footswitch control is plugged footswitch control is plugged in and available in and available Footswitch Indicator o lt gt Return Electrode O Power F an L a Alarm Monopolar Bipolar Power Indicator llluminates when the y main power is on Split Return Solid Return Alarm Indicator Electrode Indicator Electrode Indicator Illuminates when the system Illuminates green Illuminates green detects a return electrode when the system when the system alarm condition detects a split plate is detects a single properly placed on plate the patient Solid pad indicator only detects that a pad is connected to the unit The unit does not monitor pad placement on the patient 2 8 Bovie Medical Corporation POWER SWITCH AND RECEPTACLES Figure 2 7 Location of the unit power switch and front panel receptacles Return Electrode Monopolar Handswitching Receptacle Receptacle Accepts standard 3 pin handpieces Accepts a standard Connect handswitchi
13. 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 e Avoid skin to skin contact points such as fingers touching leg when positioning the patient e Place 5 to 8 cm 2 to 3 in of dry gauze between contact points to ensure that contact does not occur Position the return electrode to provide a direct current route between the surgical site and the return electrode which avoids skin to skin contact areas In addition place return electrodes according to the manufacturer s instructions Potential for alternate site burns increases if the return electrode is compromised Bovie Medical recommends the use of split return electrodes and Aaron generators with a contact quality monitoring system 4 2 Bovie Medical Corporation 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
14. pressing the up and down buttons next to the Cut power output display 2 If using Blend vary the blend setting by pressing the up and down buttons next to the blend amount indicator graph 3 Monopolar Coag select the mode of operation for coagulation Coagulation or Fulguration then select the coagu lation power settings by pressing the up and down buttons next to the Coag power output display 4 Bipolar adjust the Bipolar power settings by pressing the up and down buttons next to the Bipolar power output display 5 Activate the generator by pressing the appropriate button on the handpiece or pedal on the footswitch NOTICE Monopolar and bipolar footswitching operations are controlled by independent foot controls User s Guide e Aaron 3250 4 7 ACTIVATION SAFETY 4 8 Do not wrap the accessory cords or patient return electrode cords around metal objects This may induce currents that could lead to shocks fires or injury to the patient or surgical team Danger Fire Explosion Hazard Do not use the Aaron 3250 in the presence of flammable anesthetics Fire Explosion Hazard The following substances will contribute to increased fire and explosion hazards in the operating room e Flammable substances such as alcohol based skin prepping agents and tinctures e Naturally occurring flammable gases that may accumulate in body cavities such as the bowel e Oxygen enriched atmospheres e Oxidizing agents such as nit
15. 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 alarm indicator remains illuminated red This could indicate improper pad placement or a faulty NEM circuit 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 U S Department of Health and Human Services National Institute for Occupational Safety and Health NIOSH Control of Smoke from Laser Electric Surgical Procedures HAZARD CONTROLS Publication No 96 128 September 1996 NOTICES If required by local codes connect the generato
16. tone alerts the surgical team when an accessory is active When using a smoke evacuator in conjunction with the electrosurgical generator place the smoke evacuator a distance from the generator and set the generator volume control at a level that ensures that the activation tones can be heard NOTICE If required by local codes connect the generator to the hospital equalization connector with an equipotential cable SETTING UP 1 Verify that the generator is Off by pressing the power switch Off O 2 Place the generator on a stable flat surface such as a table platform or medical cart Carts with conductive wheels are recommended For details refer to the procedures for your institution or to local codes Provide at least 10 to 15 cm 4 to 6 in of space from the sides and top of the generator for cooling Normally the top sides and rear panel are warm when you use the generator continuously for extended periods of time 3 Plug the generator power cord into the AC Power Cable Receptacle on the rear panel 4 Plug the generator power cord into a grounded receptacle 5 Turn on the generator by pressing the power switch On Verify the following All visual indicators and displays on the front panel illuminate Activation tones sound to verify that the speaker is working properly 6 If the self test is successful a tone sounds Verify the following A Cut mode is selected a Coag mode is selected Each display shows a p
17. 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
18. al 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 e Avoid skin to skin contact points such as fingers touching leg when positioning the patient e 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 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 User s Guide Aaron 3250 1 5 1 6 CAUTIONS At no time should you touch the active electrode or bipolar forceps
19. brane switches are disabled during activation Blend amount control buttons are disabled during activation Recall and Set membrane switches are disabled during activation During activation the activated mode can be adjusted up and or down a maximum of four steps Refer to the following table for power increments POWER SETTINGS INCREMENTS FOR INSTANCE 1 50 Watts 1 Watts The unit is activated using the same preset values as described in Example 1 of this section 30 100 Watts 2 Watts While activated the Cut 1 power output of 30 watts can be 100 200 Watts 5 Watts adjusted 4 steps down to 26 watts or 4 steps up to 34 watts The Pinpoint and Bipolar can be adjusted to display a different setting 200 300 Watts 10 Watts but can not be saved during activation e While operating the unit outside of a user defined preset small red dot will be blinking in lower right corner of the Preset display as an indicator the unit temporarily stores the power setting for the activated mode Cut Coag or Bipolar This temporary power setting is available until either the unit is reset a preset is selected or the power setting for the mode in use is adjusted and the unit is again activated Presets only store one Cut mode Cut I or Cut II or Blend and power setting one Blend level if applicable one Coag mode Pinpoint or Spray and power setting and Bipolar power setting When storing only the informatio
20. cy 50 60 Hz Leakage Current Enclosure source current ground open lt 500 yA Normal polarity intact ground lt 10 HA Source current patient leads all outputs Normal polarity ground open lt 10 pA Reverse polarity ground open lt 10 yA Sink current at high line all inputs lt 10 pA User s Guide Aaron 3250 A 3 High Frequency RF Leakage Current Bipolar RF leakage current lt 63 MA mms at 80 wats Monopolar RF leakage current additional tolerance lt 150 MA ms STANDARDS AND IEC CLASSIFICATIONS Class Equipment IEC 60601 1 Accessible conductive parts cannot become live in the event of a basic insulation failure because of the way in which they are connected to the protective earth conductor Type CF Equipment IEC 60601 1 Defibrillator Proof The Aaron 3250 provides a high degree of protection against electric shock particularly regarding allowable O leakage currents It is type CF equipment Patient connections are isolated from earth and resist the effects of defibrillator discharge Drip Proof IEC 60601 2 2 The generator enclosure is constructed so that liquid spillage in normal use does not wet electrical insulation or other components which when wet are likely to affect adversely the safety of the generator Electromagnetic Interference When other equipment is placed on or beneath a Aaron 3250 the unit can be activated without interference The generator minimizes electroma
21. d IEC 60601 2 2 A 4 Voltage Transients Emergency Generator Mains Troneier A 4 O tp t Characteristics decir dais A 5 Maximum Output for Monopolar and Bipolar Modes A A 5 lees EI A 5 Output Power Curves acia A 9 Warranty sens TR RS EN Re rss en B 1 User s Guide Aaron 3250 LIST OF FIGURES vi Figure 2 1 Figure 2 2 Figure 2 3 Figure 2 4 Figure 2 5 Figure 2 6 Figure 2 7 Figure 2 8 Figure 5 1 Figure A 1 Figure A 2 Figure A 3 Figure A 4 Figure A 5 Figure A 6 Figure A 7 Figure A 8 Figure A 9 Layout of controls indicators and receptacles on the front panel 2 2 Controls for setting and recalling presets EN 2 4 Controls for the Cut and Blend modes 2 5 Controls for the Coag mode 2 6 Controls for the Bipolar mode 2 7 Indicators for power return electrodes and footswitch contmol 2 8 Location of the unit power switch and front panel receptacles 2 9 Layout of connectors and controls on the rear panel NIR EE Display setting vs output power in watts at rated load n Output voltage Vpeak versus power setting at rated load Output power vs impedance for Cut mode Output power vs impedance for Cut ll mode Output power versus impedance for Blend mode minimum A 11 Output power versus impedance for Blend mode maximum A 11 Output power vs impedance for Pinpoint
22. e next time the unit is switched on the number 2 Preset will be displayed and available when the unit is activat ed The number 2 Preset will be the same as the modes and settings indicated in Example 1 3 The physician performs a surgical procedure using Preset 2 same as Example 1 Preset values He changes the settings by selecting the Cut II mode The displayed power will remain at 30 watts The physician then adjusts the power to 100 watts He resumes the procedure now using Cut II at 100 watts He then switches the mode back to Cut I The power output returns to 30 watts as stored in the 2 Preset The physician switches again to the Cut II mode and the output power returns to the temporary memory of 100 watts as previously selected The procedure is completed without saving any modes or power settings The next time the unit is switched on the number 2 Preset will be displayed and available when the unit is activated The number 2 Preset will be the same as the modes and settings indicated in Example 1 4 The physician performs a surgical procedure using Preset 2 same as Example 1 Preset values As required in the procedure he selects the Blend mode the Blend Amount Indicator illuminates to one bar indi cating the Blend mode can be increased to the preferred amount of blend He adjusts the hemostasis level up to a 30 blend but does not store the new settings into the Preset The next time the unit is switched on the number 2 Prese
23. ect A setting of 10 is maximum hemostasis blend with minimal cutting effect This adjustment is easily achieved by an incremental adjustment Refer to Section 2 Controls Indicators and Receptacles Cut and Blend Controls The Blend mode improves the rate of targeted tissue desiccation without increasing the power delivered by the generator Presets The surgeon can store 10 user defined presets for easy recall of frequently used settings Two levels of coagulation Coagulation and Fulguration Coagulation provides precise control of bleeding in localized areas Fulguration provides greater control of bleeding in highly vascular tissue over broad surface areas Return electrode sensing and contact quality monitoring The 3250 incorporates a return electrode contact quality monitoring system Bovie NEM This system detects the type of return electrode solid or split The system also continually monitors the contact quality between the patient and the split return electrode This feature is designed to minimize patient burns at the return electrode site FDFS Fast Digital Feedback System The FDFS Fast Digital Feedback System measures voltage and current at 5 000 times a second and immediately adjusts the power to varying impedance during the electrosurgical procedure The unit s digital technology senses and responds to changes in tissue and density Unlike analog this feature reduces the need to adjust power settings manually
24. ect it to Standard 3 pin handswitching pencil Monopolar handswitching receptacle Footswitching pencil Monopolar footswitching receptacle To activate the Monopolar mode depress the cut or coag button on the monopolar handpiece or the cut or coag pedal on the monopolar footswitch 4 4 Bovie Medical Corporation PREPARING FOR BIPOLAR SURGERY 1 Connect a Bipolar cable to the Bipolar receptacle on the front of the unit 2 Connect a forceps instrument to the bipolar cable 3 Connect the bipolar footswitch to the bipolar footswitch connecting socket located on the rear of the unit To activate the Bipolar mode depress the pedal on the bipolar footswitch SETTING AND RECALLING MEMORY PRESETS The Aaron 3250 incorporates 10 user defined memory preset settings for easy recall of frequently used settings in all three modes Memory The Memory feature allows the Aaron 3250 unit to display the last selected Preset when the generator is turned on When activated by the handpiece or footswitch the unit will operate in that particular mode and power setting The small red blinking dot in the lower right hand corner of the Preset display lets the user know that the Preset val ues have been adjusted All new settings must be saved as a Preset to be available at startup or as a Preset selection 0 through 9 when using the unit Memory Function Overview The unit powers up with the last selected preset 0 9 e Mode Cut and Coag mem
25. es Inspecting the Generator and Accessories O Setup Safety O Setting Up O Preparing for Monopolar Surgery O Preparing for Bipolar Surgery O 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 e Aaron 3250 4 1 INSPECTING THE GENERATOR AND ACCESSORIES Before each use of the Aaron 3250 verify that the unit and all accessories are in good working order Inspect for damage to the Electrosurgical Generator and all its connections e Verify that the appropriate accessories and adapters are present Inspect all cords and connectors for signs of wear damage and abrasion Verify that no errors occur when you turn on the unit SETUP SAFETY Hazardous Electrical Output This equipment is for use only by trained licensed physicians Electric Shock Hazard Connect the generator power cord to a properly grounded receptacle Do not use power plug adapters Connect the power cord to a properly polarized and grounded power source with the frequency and voltage characteristics that match those listed on the back of the unit Fire Hazard Do not use extension cords Patient Safety Use the generator only if the self test has been completed as described
26. ghly visible area not in contact with the patient Inadvertent contact with the patient may result in burns Bovie Medical Corporation 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 User s Guide e Aaron 3250 4 9 Bovie Medical Corporation MAINTAINING THE AARON 3250 This section covers the following topics Cleaning Periodic Inspection Fuse Replacement User s Guide Aaron 3250 5 1 Bovie Medical recommends that you complete periodic inspection and performance testing Perform inspections and performance testing every six months A qualified biomedical technician should conduct this testing to ensure that the unit is operating effectively and safely CLEANING After each use clean the unit 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 co
27. gnetic interference to video equipment used in the operating room Electromagnetic Compatibility IEC 60601 1 2 and IEC 60601 2 2 The Aaron 3250 complies with the appropriate IEC 60601 1 2 and IEC 60601 2 2 specifications regarding electromagnetic compatibility Voltage Transients Emergency Generator Mains Transfer The Aaron 3250 operates in a safe manner when the transfer is made between line AC and an emergency generator voltage source A 4 Bovie Medical Corporation 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 Crest Factor Mode Output Power Output Frequency Repetition Rate Vpeak max Rated Load Cut 300 W 300 Q 490 kHz 4 9 kHz N A 1000V 1 6 20 Cut II 300 W 300 O 490 kHz 4 9 kHz N A 1000V 1 6 20 Blend Max 200 W 300 Q 490 kHz 4 9 kHz 30 kHz 5 kHz 2000V 3 5 20 Pinpoint 120 W 500 Q 490 kHz 4 9 kHz 30 kHz 5 kHz 2400V 4 5 20 Spray 80 W 500 Q 490 kHz 4 9 kHz 30 kHz 5 kHz 3600V 6 5 20 Bipolar 80 W 150 0 490 kHz 4 9 kHz N A 450V 1 6 20 an indication of a waveform s ability to coagulate bleeders without a cutting effect EMC COMPLIANCE Special precautions should be taken regarding the Aaron 3250 Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information pr
28. he Pure Cut I mode is selected Cut Blend Amount Indicator Indicates the amount of blend added in the Blend mode More bars illuminated indicates more blend divided into 10 steps Cut Il Mode Indicator Indicates when the Cut Il mode is selected Blend Mode Indicator Indicates when the Blend mode is selected Cut Activation Indicator Cut and Blend Illuminates when Cut or Mode Selector Blend mode is activated Toggles between Cut I Cut Il and Blend modes NOTICE When selecting the Blend mode the unit defaults to a setting of minimum blend only the first bar is illuminated User s Guide Aaron 3250 2 5 COAG CONTROLS Figure 2 4 Controls for the Coag mode Coag Power Display watts Indicates the power set for Coag Power Control Buttons the Coag mode Increases or decreases the Pinpoint or Spray Coag power output in increments of 1 to 10 watts Coag Activation Indicator Illuminates when Coag mode is activated Coag Pinpoint Mode Indicator Indicates when the Pinpoint G Co a g u a tio n mode is selected Pinpoint and Spray Mode Selector Fulguration Toggles between Pinpoint mode and Spray mode Spray Mode Indicator Indicates when the Spray mode is selected 2 6 Bovie Medical Corporation BIPOLAR CONTROLS Figure 2 5 Controls for the Bipolar mode Bipolar Power Display watts Indicates the power set for the Bipolar mode Displays error code
29. he unit output power Most error codes result from faults in accessories attached to the unit The following table lists the error codes describes the errors and recommends actions to take to resolve the errors All error codes are displayed in the Bipolar display If the unit displays any other error code it requires service Error Code Description Recommended Action F1 Cut handpiece button may be stuck 1 Turn off then turn on the generator Do not press buttons or activate F2 Coag handpiece button accessory devices during the self test may be stuck 2 If the error code reappears disconnect all accessories F3 Cut footswitch pedal may be stuck Turn off then turn on the generator again 3 Coag footswitch pedal 3 If the problem persists replace the handpiece or footswitch may be stuck and repeat the restart 4 If the error code reappears record the number and call F5 Bipolar footswitch pedal Bovie Medical Corporation customer service may be stuck The unit does not allow simultaneous activation of the cut and coagulation modes The activation mode is first come first serve This means that whichever mode is selected first will be the function the unit is activated to dispense An example of this functionality includes when the handpiece Cut button is pressed the unit is activated for Cut If a footswitch is simultaneously pressed for Coag the unit will F6 Simulta
30. imes When using electrosurgery in the same room with any of these substances or gases prevent their accumulation or pooling under surgical drapes or within the area where electrosurgery is performed Connect the power cord to a properly polarized and grounded power source with the frequency and voltage characteristics that match those listed on the back of the unit Electric Shock Hazard Connect the generator power cord to a properly grounded receptacle Do not use power plug adapters Electric Shock Hazard Always turn off and unplug the generator before cleaning Fire Hazard Do not use extension cords Patient Safety Use the generator only if the self test has been completed as described Otherwise inaccurate power outputs may result Failure of the high frequency electrosurgical equipment could result in an unintended increase of output power The instrument receptacles on this generator are designed to accept only one instrument at a time Do not attempt to connect more than one instrument at a time into a given receptacle Doing so will cause simultaneous activation of the instruments Use the lowest output setting necessary to achieve the desired surgical effect Use the active electrode only for the minimum time necessary in order to lessen the possibility of unintended burn injury Pediatric applications and or procedures performed on small anatomic structures may require reduced power settings The
31. irst unpack your Aaron 3250 inspect it visually Look for any signs of damage e Verify that the shipping package contains all items listed on the packing list If the unit or any accessories are damaged notify Bovie Medical s Customer Service immediately Do not use any damaged equipment INSTALLATION Place the Aaron 3250 on any flat surface with a tilt angle not more than 10 The unit relies on natural convection cooling Do not block its bottom or rear vents Ensure that air flows freely on all sides of the unit 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 At no time should you touch the active electrode or bipolar forceps A burn could result Setting Up the Unit 1 Verify that the Power Switch is in the Off O position and that no accessories are connected to the unit 2 Connect a hospital grade power cable to the AC power cable receptacle on the back of the unit then to a properly grounded wall outlet 3 Connect a two button monopolar pencil to the appropriate receptacle The use of Aaron pencils is recommended 4 Do not connect a patient return electrode at this time 5 Turn the unit on by switching the power s
32. mode A 12 Output power vs impedance for Spray mode ccsscesssseceeseseeeeneseeseenesees A 12 Output power vs impedance for Bipolar mode A 13 Bovie Medica Corporation INTRODUCING THE AARON 3250 This section includes the following information Key Features Components and 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 3250 1 1 KEY FEATURES The Aaron 3250 includes the latest technology This unit offers unsurpassed performance flexibility reliability and convenience It includes the following features Two Cut Modes Cut I amp 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 Figure A 1 in the Technical Specifications section of this guide Cut II is a softer cut that generates constant output power over a small range of impedances Refer to Figure A 2 in the Technical Specifications section of this guide Blend with 10 Settings The Blend mode is a combination of cutting and hemostasis The 3250 gives the surgeon freedom to adjust the desired level of hemostasis A setting of 1 is minimal blend with maximum cutting eff
33. n displayed in the display windows will be saved to the unit s memory User s Guide e Aaron 3250 4 5 Setting Your Presets Presets Select the desired preset 0 9 by pressing the recall button Select the desired modes to be stored by pressing the mode membrane switches Cut and Select Set Coag If presetting the Blend mode select the desired level of hemostasis Blend Bar 1 10 by pressing the Blend amount control button Select the desired power Cut Coag and Bipolar to be stored by using the power output up and down membrane switches Once all of the settings are selected depress and hold the Set button for three seconds To indicate the settings have been stored the Preset Memory Number 0 9 will blink To recall a Preset repeatedly press the Recall button to toggle through all of the presets Notices The Aaron 3250 incorporates 10 factory set presets that are all set to zero and can be reset to your preferred settings A small red dot blinking in the lower right corner of the Preset indicator display indicates that the unit is not presently set to a user defined preset Set and Recall buttons are disabled while the unit is activated Presets only store one Cut mode Cut I or Cut II or Blend and power setting one Blend level if applicable one Coag mode Pinpoint or Spray and power setting and Bipolar power setting When storing only the information displayed in the display windows will be saved to the
34. neous activation error continue in the Cut mode as long as the handpiece Cut button is pressed If the Cut button is released the unit will sense an error and both functions will be disabled 1 Release either the cut or coag button on the handpiece or the cut or coag pedal on the footswitch 2 If the error code reappears record the number and contact Bovie Medical Corporation customer service E1 Output current out of specification 1 Turn the unit off E2 Dosage voltage error 2 Turn the unit on 3 If the error code reappears record the number and contact E3 Dosage current error Bovie Medical Corporation customer service E4 DC power error E5 1 Turn the unit off l 2 Allow the unit to cool for 20 minutes Internal temperature of a section of ES the unit exceeded the limit a EEN i 4 If the error code reappears record the number and contact E7 Bovie Medical Corporation customer service 1 Turn the unit off ar 2 Turn the unit on Ea MEMEO Emot 3 If the error code reappears record the number and contact Bovie Medical Corporation customer service NOTICE If the unit does not power on to display an error check fuses as described in Section 5 of this guide 6 2 Bovie Medica Corporation ZZ SOHO IN REPAIR POLICY AND PROCEDURES Refer to this section for information on Responsibility of the Manufacturer Returning the Generator for Service User s Guide Aaron 3250 7 1 RESPONSIBILITY OF THE MANUFACTURER
35. ng accessories return electrode plug Return Me es Bipolar gt Power On Off Switch Monopolar LL Receptacle Bipolar SS Turns the unit on or off Accepts cables or adapters equipped Accepts standard cables for with standard Bovie 12 active plugs bipolar handpieces Connect Connect footswitching accessories bipolar accessories User s Guide Aaron 3250 2 9 REAR PANEL Figure 2 8 Layout of connectors and controls on the rear panel Symbols on the Rear Panel Refer to the following table for descriptions of symbols found on the rear panel of the Aaron 3250 SYMBOLS DESCRIPTION vy Equipotential Ground Stud Gd Non ionizing Radiation Volume Control Danger Explosion Risk If Used With Flammable Anesthetics Y 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 2 10 Bovie Medical Corporation GETTING STARTED This section includes the following information Initial Inspection Installation Function Checks Performance Checks User s Guide e Aaron 3250 3 1 INITIAL INSPECTION When you f
36. nt 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 alarm indicator remains illuminated red This could indicate improper pad placement or a faulty NEM circuit 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 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 hi
37. ntrol procedure Do not allow fluids to enter the chassis Do not sterilize the generator PERIODIC INSPECTION Every six months visually inspect the Aaron 3250 for signs of wear or damage In particular look for any of the following problems Damage to the power cord Damage to the power cable receptacle e Obvious damage to the unit Damage to any receptacle e 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 Figure5 1 Fuse holder If the unit does not display an error and does not power on check fuses 5 2 Bovie Medical Corporation TROUBLESHOOTING This section includes Error Code Descriptions and actions to take to resolve them User s Guide Aaron 3250 6 1 The Aaron 3250 includes automatic self diagnostics If the diagnostics detect an error the system displays an error code sounds an audible tone and disables t
38. odes Figure A 2 illustrates the maximum peak volt age available at a given power setting and output mode Figures A 3 through A 9 illustrate specific output power delivered to a range of load resistances for each mode Figure A 1 Display setting vs output power in watts at rated load Display Setting VS Output Power at Rated Load 300 E 250 4 3 200 S 150 E S 100 a 5 a 3 50 T Pal j 0 v i 0 50 100 150 200 250 300 Display Setting Figure 2 Output voltage Vpeak versus power setting at rated load POWER SETTING VS VOLTAGE Vpeak 3000 2500 2000 1500 Pinpoint VOLTAGE Vpeak 1000 Blend Max 500 1 50 100 150 200 250 300 POWER SETTING W User s Guide Aaron 3250 A 9 Figure A 3 Output power versus impedance for Cut I mode CUT I 350 300 250 200 150 100 Output Power Watts 50 500 1000 Load Resistance Ohms 300W 150W Figure A 4 Output power versus impedance for Cut I mode Cut 11 350 1500 2000 Output Power Watts ka ha nu hi Lal o un CH un o o a a a o un a 0 500 1000 Load Resistance Ohms 300 W 150 W 1500 2000 Bovie Medical Corporation Figure A 5 Output power versus impedance for Blend Min mode Blend Minimum 225 200 175 150 125 100 75 50 Output Power Watts 25 D 500 1000 1500 2000 Load Resistance Ohms
39. on site and placement procedures When using metal plate return electrodes use a conductive gel specifically designed for electrosurgery Select a return electrode site with good blood flow While a properly applied electrode results in minimal tissue heating beneath the electrode a good blood flow helps carry heat away from the site 1 Connect the cable to the Return Electrode receptacle on the front of the unit The unit will automatically sense the presence of a split or solid return electrode and if a split return electrode is used will constantly monitor the resistance at the contact between the electrode and the patient 2 Adjust the Blend setting to the desired amount of hemostasis Level 1 10 Adjustment is preformed by pressing the up or down buttons next to the Blend setting indicator Select the desired power settings for Cutting Adjustment is preformed by pressing the up or down buttons next to the Cut display Select the mode of operation for Coagulation either Coagulation or Fulguration Select the desired power setting for Coagulation Adjustment is preformed by pressing the up or down buttons next to the Coag display Connecting Accessories 1 Connect a 3 pin monopolar device into the monopolar receptacle on the front of the unit If footswitching control capabilities are preferred connect the Aaron monopolar footswitch to the appropriate footswitch connecting socket on the rear of the unit If you are using Conn
40. ored and used in a room temperature of approximately 770 F 250 C Ambient temperature range 40 to 70 C Relative humidity 10 to 100 including condensation Atmospheric pressure 50kPa to 106kPa A 2 Bovie Medical Corporation Audio Volume The audio levels stated below are for activation tones cut coag and bipolar and alarm tones return electrode and system alarms at a distance of one meter Alarm tones meet the requirements for IEC 60601 2 2 Activation Tone Volume adjustable 40 to 65 dB Frequency Cut I 610 Hz Cut Il 610 Hz Blend 610 Hz Pinpoint 910 Hz Spray 910 Hz Bipolar 910 Hz Duration Continuous while the generator is activated Alarm Tone Volume not adjustable 70 dB 5 dB Frequency 2 kHz seconds 1 kHz seconds Duration 2 seconds Return Electrode Sensing The system presents audible and visible alarms when it senses no return electrode Trip resistance 0 Q to 5 Q 30 Continuous measurement Once the system establishes the solid return electrode resistance an increase to 20 Q 5 Q in resistance will cause an alarm When the alarm condition exists the system deactivates output power Trip resistance 10 Q 5 Q to 135 O 10 O Continuous measurement Once the system establishes the split return electrode resistance an increase of 40 in resistance will cause an alarm When the alarm condition exists the system deactivates output power Low Frequen
41. ovided 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 3250 The Aaron 3250 and its accessories are not suitable for interconnection with other equipment Portable and mobile RF communications equipment can affect Medical Electrical Equipment The Aaron 3250 should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the Aaron 3250 should be observed to verify normal operation in the configuration in which it will be used User s Guide Aaron 3250 A 5 Recommended separation distances between portable and mobile RF communications equipment and the Aaron 3250 The Aaron 3250 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Aaron 3250 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Aaron 3250 as recommended below according to the maximum output power of the communications equipment Rated maximum output separation distance according to frequency of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 25vP E power of transmitter
42. ower setting The unit automatically powers up to the last selected setting The Patient Return Electrode Alarm Indicator illuminates red If the self test is not successful an alarm tone sounds An error code will appear in the Bipolar display in most cases the generator is disabled Note the error code and refer to Section 6 Troubleshooting Once the self test is successful connect the accessories and set the generator controls Refer to Preparing for Monopolar Surgery or Preparing for Bipolar Surgery later in this section User s Guide Aaron 3250 4 3 PREPARING FOR MONOPOLAR SURGERY Monopolar surgery requires a return electrode Applying the Return Electrode To maximize patient safety Bovie Medical recommends using a split return electrode and a Aaron generator with a contact quality monitoring system Bovie NEMTM 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 5 to 10 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 Refer to the manufacturer s instructions for applicati
43. piece Receptacle Cut Mode VV A Bipolar Mode o Ol Bipolar Handpiece Receptacle User s Guide Aaron 3250 2 3 PRESET CONTROLS Figure 2 2 Controls for setting and recalling presets Preset Number Display Indicates the current selection of one of the 10 presets 0 9 Recall Button Presets Toggles through the 10 presets Stop at the desired number 0 9 illumi oe nated in the Preset Number Display ES to recall a Preset 2 Select Set Set Button Sets the desired preset into one of V the 10 user defined presets Press Preset Indicator LED and hold the Set button for three Blinks in the lower right corner of seconds to save the settings the Preset display to indicate that the current setting is not one of the user defined presets NOTICES The Aaron 3250 incorporates 10 factory set presets that are all set to zero and can be reset to your preferred settings Set and Recall are disabled while the unit is activated 2 4 Bovie Medical Corporation CUT AND BLEND CONTROLS Figure 2 3 Controls for the Cut and Blend modes Blend Amount Control Buttons Cut Power Display watts Cut Power Control Buttons Increases or decreases the Increases or decreases the Cut or Indicates the power set for ges amount of blend Level 1 10 the Cut Blend mode Blend power output in increments added in the Blend mode of 1 to 10 watts Cut I Mode Indicator Indicates when t
44. poration S FA DE AGNET Fr TEGHNIGAL SPEGIFIGATIONS All specifications are nominal and subject to change without notice A specification referred to as typical is within 20 of a stated value at room temperature 25 C 77 F and a nominal input power voltage User s Guide Aaron 3250 A 1 PERFORMANCE CHARACTERISTICS Input Power Input Voltage 100 240 VAC 10 Mains line frequency range nominal 50 60 Hz Power consumption 560 VA Fuses two 6 3 A slow blow Duty Cycle Under maximum power settings and rated load conditions Pure Cut 300 watt 300 ohm load the generator is suitable for activation times of 10 seconds ON followed by 30 seconds OFF for one hour The internal temperature of the unit is continuously monitored If the temperature rises above 850 C the alarm will sound and output power will be deactivated Dimensions and Weight Width 31 1 cm 12 25 in Depth 41 3 cm 16 25 in Height 15 3 cm 6 00 in Weight lt 8 75 kg lt 19 lbs Operating Parameters Ambient temperature range 10 to 40 C Relative humidity 30 to 75 non condensing Atmospheric pressure 70kPa to 106kPa If transported or stored at temperatures outside the operating temperature range Warm up time P allow one hour for the generator to reach room temperature before use Transport and Storage Generator should fit on all standard Carts for monopolar generators The device should be st
45. r to the hospital equalization connector with an equipotential cable Do not clean the generator with abrasive cleaning or disinfectant compounds solvents or other materials that could scratch the panels or damage the generator Bovie Medica Corporation CONTROLS INDICATORS AND RECEPTACLES This section describes o The Front and Rear Panels Controls Indicators Receptacles and Ports User s Guide Aaron 3250 2 1 FRONT PANEL Figure 2 1 Layout of controls indicators and receptacles on the front panel Presets Se Cut K Coaguianon cA Ee Cur Y E j Gui Futguration Select Sot A Footswrich Indicator er flown Electrode eo e lt gt Wien F SR E Qan A P Moncpata Bipotar 2 2 Bovie Medical Corporation Symbols on the Front Panel Refer to the following table for descriptions of symbols found on the front panel of the Aaron 3250 SYMBOLS DESCRIPTION Cut Controls Cut Mode JL Blend Mode Al Pinpoint Mode B Spray Mode Bipolar Controls Bipolar Mode Indicators as Split Return Electrode sn Solid Return Electrode Regulatory Symbology Cli Read instructions before use 4 9 Defibrillator Proof Type CF Equipment F RF Isolated patient connections are isolated from earth at high frequency Power Switch and Handpiece Connectors SS Return Electrode Receptacle Y Caution High Voltage Coag Mode ROIS Monopolar Hand
46. rous oxide N O atmospheres The sparking and heating associated with electrosurgery can provide an ignition source Observe fire precautions at all times When using electrosurgery in the same room with any of these substances or gases prevent their accumulation or pooling under surgical drapes or within the area where electrosurgery is performed Use the lowest output setting necessary to achieve the desired surgical effect Use the active electrode only for the minimum time necessary in order to lessen the possibility of unintended burn injury Pediatric applications and or procedures performed on small anatomic structures may require reduced power settings The higher the current flow and the longer the current is applied the greater the possibility of unintended thermal damage to tissue especially during use on small structures Use electrosurgery with caution in the presence of internal or external devices such as pacemak ers or pulse generators Interference produced by the use of electrosurgical devices can cause devices such as pacemakers to enter an asynchronous mode or can block the pacemaker effect entirely Consult the device manufacturer or hospital Cardiology Department for further information when use of electrosurgical appliances is planned for patients with cardiac pacemakers or other implantable devices CAUTIONS The use of high frequency current can interfere with the function of other electromagnetic equipme
47. stand and follow the operating instructions supplied with this electrosurgical equipment Physicians have used electrosurgical equipment safely in numerous procedures Before starting any surgical procedure the surgeon should be familiar with the medical literature complications and hazards of using electrosurgery in that procedure To promote the safe use of the Aaron 3250 this section presents the warnings and cautions that appear throughout this user s guide It is important that you read understand and follow the instructions in these warnings and cau tions 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 Hazardous Electrical Output This equipment is for use only by trained licensed physicians Danger Fire Explosion Hazard Do not use the Aaron 3250 in the presence of flammable materials Fire Explosion Hazard The following substances will contribute to increased fire and explosion hazards in the operating room e Flammable substances such as alcohol based skin prepping agents and tinctures e Naturally occurring flammable gases which may accumulate in body cavities such as the bowel e Oxygen enriched atmospheres e Oxidizing agents such as nitrous oxide N 0 atmospheres The sparking and heating associated with electrosurgery can provide an ignition source Observe fire precautions at all t
48. t 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 Bovie Medical Corporation 5115 Ulmerton Road Clearwater FL 33760 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 sales boviemed com MC 55 104 001 Rev 4 geng 2013 03 15
49. t will be displayed and available when the unit is activated The number 2 Preset will be the same as the modes and settings indicated in Example 1 5 The physician performs a surgical procedure using Preset 2 same as Example 1 Preset values He adjusts the power settings for a Cut mode a Coag mode and a Bipolar mode and presses the Store button for three seconds to save the new settings as Preset number 2 The next time the unit is switched on the number 2 Preset will be dis played and available when the unit is activated The number 2 Preset will now be the last saved Preset settings for Preset 2 ACTIVATING THE UNIT NOTICE Review Activation Safety on page 8 of this section before activating the unit When you turn on your unit remember the following feature The Aaron 3250 will power up to the settings displayed when the unit was last activated For example if you set the Cut mode at 50 watts and activate the unit then turn the unit off it will automatically return to Cut at 50 watts when you turn it on again Similarly if you set Coagulation mode at 40 watts and activate the unit before you turn it off it will return to Coagulation mode at 40 watts when you turn it on again During activation the activated mode can be adjusted up and or down a maximum of four steps Refer to the following table for power increments 1 Monopolar Cut select the mode of operation for Cut or Blend then select the desired Cut power settings by
50. tion during power EE 9 mains interruptions it is ply input lines 70 A Ui e 70 h Ut EES V IEC 61000 4 11 lt 30 dip in U lt 30 dip in U recommended that the Aaron for 25 cycles for 25 cycles 3250 be powered from an uninterruptible power supply or a lt 5 U lt 5 U gt 95 dip in U gt 95 dip in U battery for 5 sec for 5 sec Power frequency magnetic fields Power frequency 50 60 should be at levels characteristic Hz magnetic field of a typical location in a typical IEC 61000 4 8 commercial or hospital environment NOTE U is the a c mains voltage prior to application of the test level User s Guide Aaron 3250 A 8 Guidance and manufacturer s declaration electromagnetic immunity continued IEC 60601 Immunity test test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Aaron 3250 including cables than the Conducted RF 3 Vrms recommended separation distance calculated IEC 61000 4 6 ae to 80 from the equation applicable to the frequency of the transmitter Recommended separation distance tee Vi d r 32 54 p E 80 MHz to 800 MHz dE 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the 3 V m transmitter manufacturer and d is the Radiated RF 80 MHz to recommended separation distance in me
51. tres IEC 61000 4 3 2 5 GHz m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following 0 symbol A 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 4 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 3250 is used exceeds the applicable RF compliance level above the Aaron 3250 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Aaron 32507M b Over the frequency range 150 kHz to 80 MHz field strengths should be less than V4 V m Bovie Medical Corporation OUTPUT POWER CURVES Figure A 1 illustrates output power delivered to rated load for all available m
52. units memory Memory Feature Last Selected Preset The Memory feature allows the unit to display the last selected power preset when the generator is turned on NOTICE To have a setting selection available at startup or to be one of the 10 user defined presets the adjustment to the mode and or power settings must be saved by pressing the Set button on the Preset display panel Examples Examples 1 through 4 explain how the Memory and temporary memory features work and what happens when the power and or mode is adjusted but not saved as one of the 10 Preset selections Example 5 explains what happens when the power and or mode is adjusted and saved as a new Preset setting 1 The physician performs a surgical procedure using Preset 2 The Preset has been stored with the following mode and power The mode is set to Cut I The power setting for Cut I is 30 watts The power setting for Pinpoint is 15 watts The power setting for Bipolar is 20 watts The procedure is completed and the unit is switched off The next time the unit is switched on the number 2 Preset will be displayed and available when the unit is activated The number 2 Preset will be the same as the modes and settings indicated above 2 The physician performs a surgical procedure using Preset 2 same as Example 1 Preset values He adjusts the power settings for each mode but does not store the new settings into the Preset 4 6 Bovie Medical Corporation Th
53. urgery 4 4 Applying the Return Electrode 4 4 Een ue 4 4 Preparing for Bipolar Surgery 4 5 Setting and Recalling Memory Presets AAA 4 5 EL dene Dee Eed ir rt 4 5 Memory Function Overview 4 5 Setting Your Presets aiii ice 4 6 Memory Feature Last Selected Preset ENEE 4 6 Activating BACHE 4 7 Activation lebt eier 4 8 Maintaining KT TG IEN 5 1 Cleaning EE 5 2 Penodi INSPOCtlOr sa A tn 5 2 Fuse Replacement iiiaiialuatinialan sais deed 5 2 iv Bovie Medica Corporation Troubleshooting nn 6 1 Repair Policy and Procedures nn 7 1 Responsibility of the Manufacturer 7 2 Returning the Generator for Service ENEE 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 nee A 1 Performance Characteristics A 2 PUE EE A 2 Nee EE A 2 Dimensions and Welgh ticas poned A 2 Operating Parameters A 2 Transport and Storage 2e nn RS o e net ON A 2 Audio We A 3 Return Electrode Sensing erger eene A 3 Low Frequency 50 60 Hz Leakage Current EEN A 3 High Frequency RF Leakage Current A 4 Standards and IEC Classifications AEN A 4 Class Equipment IEC GOp01 2 A 4 Type CF Equipment IEC 60601 1 Defibrillator Proof A 4 Drip Proof EG 60601 22 EE A 4 Electromagnetic Interference EEN A 4 Electromagnetic Compatibility IEC 60601 1 2 an
54. w on the footswitch Verify that the Cut mode activation indicator illuminates and that the system generates the Cut activation tone 4 While activating the Cut mode rotate the volume control over the full range to verify that the sound is audible throughout the range 5 Press the Coag pedal blue on the footswitch Verify that the Coag mode activation indicator illuminates and that the system generates the Coag activation tone 6 While activating the Coag mode rotate the volume control over the full range to verify that the sound is audible throughout the range Checking Monopolar Mode with handswitch 1 Connect a handswitching handpiece to the Monopolar handpiece receptacle 2 Connect a solid return electrode to the return electrode receptacle Verify that the green solid return electrode indicator illuminates 3 Activate one at a time the Cut and Coag handswitching controls Verify that each control causes the correct indicator and tone to sound PERFORMANCE CHECKS After the unit has passed the preliminary functional test it is ready for performance testing A qualified biomedical engineer who is thoroughly familiar with electrosurgical devices should conduct this testing The testing should include checking all modes of operation for proper function and power output User s Guide Aaron 3250 3 3 3 4 Bovie Medical Corporation IM fa USING THE AARON 32507 This section contains the following procedur
55. witch to the On position Checking the Return Electrode Alarm 1 Adjust the power settings for each mode Cut Coag Bipolar to one watt 2 Press the Coag button of the pencil Verify that an alarm sounds for three seconds and the patient return electrode sensing alarm indicator light illuminates indicating that no return electrode is connected to the unit 3 Verify that adjusting the volume control on the back of the unit while the alarm is sounding does not change the alarm volume 3 2 Bovie Medica Corporation Confirming Modes Confirm that you can select each mode and adjust the power up and down Checking Bipolar Mode with bipolar footswitch 1 Plug in the Bipolar footswitch Verify that the Bipolar footswitch indicator illuminates 2 Press the pedal on the Bipolar footswitch Verify that the Bipolar mode activation indicator illuminates and that the system generates the Bipolar activation tone 3 While activating the Bipolar mode rotate the volume control over the full range to verify that the sound is audible throughout the range 4 Confirm that releasing the pedal returns the unit to an idle state Checking Monopolar Mode with monopolar footswitch 1 Plug in the Monopolar footswitch Verify that the monopolar footswitch indicator illuminates 2 Connect a solid return electrode to the return electrode receptacle Verify that the green solid return electrode indicator illuminates 3 Press the Cut pedal yello

Aaron 3250 User Guide - Bovie Medical Corporation

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