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1. Figure 3 1 Mounting kit 2 Plug the female end of the supplied power cord into the base of the unit and the male end into a grounded wall receptacle 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 3 2 Bovie Medical Corporation USING THE AARON 9507 This section contains the following procedures O Inspecting the Generator and Accessories O Setup Safety O Setting Up O Preparing for Monopolar Surgery O Preparing for Bipolar Surgery O Activation Safety O Activating the Unit CAUTIONS Read all warnings cautions and instructions provided with this generator before use Read the instructions warnings and cautions provided with electrosurgical accessories before use Specific instruc tions are not included in this manual User s Guide Aaron 950 INSPECTING THE GENERATOR AND ACCESSORIES Before each use of the Aaron 950 Electrosurgical Generator verify that the unit and all accessories are in good working order e Inspect for damage to the Electrosurgical Generator and all its connections e Verify that the appropriate accessories and adapters are present e Inspect all cords and connectors for signs of wear damage and abrasion e Verify that no errors occur when you turn on the unit SETUP SAFETY WARNINGS e AS Hazardous Electrical Output This equipm
2. This section covers the following topics Cleaning Periodic Inspection User s Guide Aaron 950 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 Electric Shock Hazard Always turn off and unplug the generator before cleaning NOTICE Do not clean the generator with abrasive cleaning or disinfectant compounds solvents or other materials that could scratch the panels or damage the generator 1 Turn off the generator and unplug the power cord from the wall outlet 2 Thoroughly wipe all surfaces of the generator and power cord with a mild cleaning solution or disinfectant and a damp cloth Follow the procedures approved by your institution or use a validated infection control procedure Do not allow fluids to enter the chassis Do not sterilize the generator PERIODIC INSPECTION Every six months visually inspect the Aaron 950 Electrosurgical Generator for signs of wear or damage In particular look for any of the following problems e Damage to the power cord e Damage to the power cable receptacle e Obvious damage to the unit e Damage to any receptacle e Accumulation of lint or debris in or around the unit Bovie Medic
3. Figure A 3 Output power versus impedance for blend mode BLEND Mode 60W 30W 100 90 80 70 60 W 50 40 30 20 10 0 0 500 1000 1500 2000 2500 3000 Ohm Figure A 4 Peak voltage versus power setting for blend mode Open Circuit Peak Voltage Volts 0 1 5 10 15 20 25 30 35 40 45 50 55 60 Output Power Setting Watts A 10 Bovie Medical Corporation Monopolar Coag Curves These measurements were taken using short lt 0 5 meter leads Figure A 5 Output power versus impedance for coagulation mode 100 90 COAG Mode 60W 30W 805 STS TNT 70 60 W 50 40 30 a PI Pi een enne nei eee ee elia TTT 20 10 0 500 1000 1500 2000 2500 3000 Ohm Figure A 6 Peak voltage versus power setting for coagulation mode 4000 3500 3000 2000 1500 1000 Open Circuit Peak Voltage Volts 500 0 1 5 10 15 20 2 30 35 40 45 50 55 60 Output Power Setting Watts User s Guide Aaron 950 A 11 Figure A 7 Output power versus impedance for fulguration mode FULGURATION Mode 35W 18W 50 45 40 35 0 500 1000 1500 2000 2500 3000 Ohm Figure A 8 Peak voltage versus power setting for fulguration mode 6500 6000 5500 5000 450
4. Use electrosurgery with caution in the presence of internal or external devices such as pacemakers or pulse genera tors 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 perfora tion 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 patient return electrode that includes the
5. Aaron 950 A 7 OUTPUT CHARACTERISTICS Maximum Output for Bipolar and Monopolar Modes Power readouts agree with actual power into rated load to within 20 or 5 watts whichever is greater Mode Output Power Output Frequency Repetition Rate Vpeak Cut 60W 5000 357 kHz 50 kHz N A 1 5 KV Blend 60 W 800 0 357 kHz 50 kHz 30 kHz 5 kHz 2 0 KV Coagulation 60W 10000 375 kHz 50 kHz 60 kHz 5 kHz 3 8 KV Fulguration 35W 10000 575 kHz 50 kHz 30 kHz 5 kHz 6 5 KV Bipolar 30W 2000 520 kHz 14kHz 50 kHz 19 kHz 5 kHz 2 0 KV A 8 Bovie Medical Corporation OUTPUT POWER CURVES The curves that follow depict the changes for each mode at specific power settings Monopolar Cut Curves These measurements were taken using short lt 0 5 meter leads For each output power vs impedance curve the upper curve represents readings taken at full power the lower curve readings taken at half power Figure A 1 Output power versus impedance for cut mode CUT Mode 60W 30W 100 90 80 70 60 W 50 40 30 20 3 10 0 0 500 1000 1500 2000 2500 3000 Ohm Figure A 2 Peak voltage versus power setting for cut mode 1400 1200 fon Q O oo Q O D So oO gt o oO Open Circuit Peak Voltage Volts 200 0 1 5 10 15 20 2 30 35 40 45 50 55 60 Output Power Setting Watts User s Guide Aaron 950
6. Defibrillator ICD contact the ICD manufacturer for instructions before performing an electrosurgical procedure Electrosurgery may cause multiple activation of ICDs In some circumstances potential exists for alternate site burns at points of skin contact e g between the arm and the side of the body This occurs when electrosurgical current seeks a path to the patient return electrode that includes the skin to skin contact point Current passing through small skin to skin contact points is concentrated and may cause a burn This is true for grounded ground referenced and isolated output generators To reduce the potential for alternate site burns do one or more of the following Avoid skin to skin contact points such as fingers touching leg when positioning the patient Place 5 to 8 cm 2 to 3 in of dry gauze between contact points to ensure that contact does not occur Position the patient return electrode to provide a direct current route between the surgical site and the return electrode which avoids skin to skin contact areas e In addition place patient return electrodes according to the manufacturer s instructions Potential for alternate site burns increases if the return electrode is compromised 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 configu rations are unstable and or do not allow adequate cooling P
7. RF output is isolated from Q Coag u lati on the ground Power Output Control Knob Tum clockwise to increase Coag Mode Selector Coag Indicator power output counterclock When pressed selects the Indicates when wise to decrease power coagulation mode coagulation mode is output selected 2 4 Bovie Medical Corporation FULGURATION BIPOLAR AND PRESET CONTROLS Figure 2 3 Controls for the fulguration and bipolar modes and presets J i TE Power Display watts Fulauration Indicator Cut Blend Active Indicator Indicates the power set for the 9 Indicates that the power selected mode Indicates when has been activated in the selected Fulguration Mode fulguration mode mode Selector is selected When pressed selects pa the fulguration mode Bipolar Mode Selector When pressed selects the Ful gura tion Coag Fulguration Bipolar gt P f bipolar mode Q Active Indicator H Indicates that the power s Act Ive has been activated in the Bipolar Indicator 19 Bipolar selected mode Indicates when bipolar mode is selected RF Ground Referenced A7 Power Control Indicator Indicates when the RF output is ground refer Presets enced Only applies to See Power Output the fulguration mode Control Knob Turn clockwise to increase power output counterclock Recall Set wise to decrease power output Presets Display Presets Recall Selector Presets Set Button Indicates which preset is sele
8. in 1 watt increments below ten watts and in whole numbers from ten to 30 watts NOTICE The output settings cannot be adjusted when the unit is being activated 6 The unit is now ready to perform surgery Refer to Activating the Unit later in this section User s Guide Aaron 950 4 5 ACTIVATION SAFETY VARNING S re e a a a a aer 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 950 Electrosurgical Generator in the presence of flammable anesthetics Fire Explosion Hazard The following substances will contribute to increased fire and explosion hazards in the operating room Flammable substances such as alcohol based skin prepping agents and tinctures Naturally occurring flammable gases that may accumulate in body cavities such as the bowel Oxygen enriched atmospheres Oxidizing agents such as nitrous oxide N70 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 accumu lation or pooling under surgical drapes or within the area where electrosurgery is performed Use the lowest output setting necessary to achieve
9. 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 Examine all accessories and connections to the electrosurgical generator before use Ensure that the accessories func tion as intended Improper connection may result in arcs sparks accessory malfunction or unintended surgical effects When not using active accessories place them in a holster or in a clean dry nonconductive and highly visible area not in contact with the patient Inadvertent contact with the patient may result in burns 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 evacua tor 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 4 6 Bovie Medical Corporation ACTIVATING THE UNIT Monopolar Activation 1 If the unit is not already set up follow the set up procedure to prepare the unit for operation 2 Remove the handpiece from the holder Place the handpiece in the desi
10. 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 taal BOVIE MEDICAL CORPORATION 5115 Ulmerton Road Clearwater Florida 33760 U S Phone 1 800 537 2790 e Fax 1 800 323 1640 International Phone 1 727 384 2323 e www boviemed com MC 55 055 001 REV 8 Y 2013 03 19 a
11. 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 alter nate 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 User s Guide Aaron 950 1 3 WARNINGS Position the patient return electrode to provide a direct current route between the surgical site and the return electrode which avoids skin to skin contact areas e In addition place patient return electrodes according to the manufacturer s instructions Potential for alternate site burns increases if the return electrode is compromised Do not wrap the accessory cords or patient return electrode cords around metal objects This may induce currents that could lead to shocks fires or injury to the patient or surgical team CAUTIONS At no time should you touch the active electrode or bipolar forceps A burn could result Do not stack equipment on top of the generator or place the generator on top of electrical equipment These configurations are unstable and or do not allow adequate cooling Provide as much distance as possible between the electrosurgical generator and other electronic equipment such as
12. the reusable grounding cord into the Patient Plate receptacle located to the right of the monopolar output see figure 4 1 letter Remove the disposable dispersive electrode from its pouch and attach to the snap connector on the end of the reusable grounding cord NOTICE A return electrode is not required for the fulguration mode The patient plate alarm is not used for this mode Procedures may be performed without the use of a return electrode 5 An optional footswitch may be used with monopolar procedures If the footswitch is utilized plug the footswitch cable into the footswitch jack see figure 4 1 letter E While using a footswitch the output will be delivered via the hand piece The activation button on the handpiece will continue to function while a footswitch is connected to the unit 4 4 Bovie Medical Corporation 6 Choose the Monopolar mode of operation by pressing the desired membrane switch on the front panel see figure 4 1 letter A Monopolar modes include Cut Blend Coagulation and Fulguration 7 Set the output power either by using the dial on the front of the unit see figure 4 1 letter J or by the up and down but tons on the handpiece see figure 4 1 letter K When power level adjustment is being made by the handpiece an audible tone will sound to indicate that the power level has been changed Depressing and holding the up or down buttons will cause the power settings to change more rapidly for quick adjustmen
13. 0 4000 3500 3000 2500 2000 1500 1000 500 0 Open Circuit Peak Voltage Volts 0 1 5 1 1 2 42 30 35 Output Power Setting Watts Bovie Medical Corporation Bipolar Curves Figure A 9 Output power versus impedance for bipolar mode BIPOLAR Mode 30W 15W 50 45 40 35 0 500 1000 1500 2000 2500 3000 Ohm Figure A 10 Peak voltage versus power setting for bipolar mode 2000 eak Voltag Open Circuit P 0 1 5 10 15 20 25 30 Output Power Setting Watts User s Guide Aaron 950 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
14. CE ee AARON 950 gt a HIGH FREQUENCY DESICCATOR Cut Fulguration a en Blend c Bipolar Power Control e F e E Coagulation Presets gt A RI Recall Set Eos sO gt TE Patient Plate U a Monopolar Alarm Bipolar Footswitch 4 4 4 q USER S GUIDE Pl TT _12121 1111 A KR Recall Set x zk us U L Monopolar Alarm Bipolar Footswitch User s Guide Aaron 950 i 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 950 Electrosurgical Generator only Additional technical information is available in the Aaron 950 Service Guide Equipment Covered in this Manual Aaron 950 Electrosurgical Generator 110 VAC Model No A950 220 VAC Model No A950 220 For Information Call 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 Aaron Part Number MC 55 055 001 Rev 8 CONVENTIONS USED IN THIS GUIDE Indicates a potentially hazard
15. Figure 2 1 Layout of controls indicators and receptacles on the front panel sssssecccsssssesscessseeseceeeenes 2 2 Figure 2 2 Controls for the cut blend and coag MODES ssssssssccsssseccssesccssssessssescesssuccessescesssnscessecessseseesses 2 4 Figure 2 3 Controls for the fulguration and bipolar modes and presets sssrrcrrecerreseenieree 2 5 Figure 2 4 Indicators and receptacles sscsssscssssssscsssscsssssscssussccssssecsusscessssscssssccesssuscssssccesssnsecsueccessseeeesees 2 6 Figure 2 5 Layout of controls and indicators on the rear and side panels ssssccsssssseccesssssetseessseeeeceeeeees 2 7 Figures T Mounting kit ainainen A izle coun eat 3 2 Figure 4 1 Setup procedures ssssssssssssssssssssvssscssssscssvssccsssvsssssssccsssussssvssccsssussssvssecsssescesvsseesssescesseseesssessesves 4 8 Figure A 1 Output power versus impedance for cut MOdE ssssssccsssccssssescssssecsssssscssssccsssssccessescsssseecesssees A 9 Figure A 2 Peak voltage versus power setting for cut mode ssssscssssccssssescssssccsssssscssseecsssssscessescsssneccesssees A 9 Figure A 3 Output power versus impedance for blend MOde ssscssssssccsssecssssseccssssesssseecsssssesesseccesssees A 10 Figure A 4 Peak voltage versus power setting for blend MOde sssssssssscssseccsssssccsssecssssseccsssecsssseecssssees A 10 Figure A 5 Output powe
16. al Corporation TROUBLESHOOTING This section includes error code descriptions and actions to take to resolve them User s Guide Aaron 950 6 1 The Aaron 950 Electrosurgical Generator includes automatic selfdiagnostics 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 error and recommends actions to take to resolve the error Error Code Description Recommended Action 1 Turn off then turn on the generator Do not press buttons or activate accessory devices during the self test 2 If the error code reappears disconnect all accessories Handswitch or monopolar Turn off then turn on the generator again footswitch pedal may be stuck 3 If the problem persists replace the handpiece or footswitch and repeat the restart 4 If the error code reappears record the number and call Bovie Medical Corporation customer service F1 Turn the unit off Verify that the unit is connected to the correct line voltage If the error code reappears record the number and contact Bovie Medical Corporation customer service MN Line voltage error i Line voltage is too high ao Turn the unit off 2 Allow the unit to cool for 20 minutes 3 Turn the unit on 4 If the error
17. ation Atmospheric pressure 50kPa to 106kPa A 2 Bovie Medical Corporation Audio Volume The audio levels stated below are for activation tones bipolar cut and coag and alarm tones return electrode and system alarms at a distance of one meter Alarm tones meet the requirements for IEC 60601 2 2 Activation Tone Volume adjustable 40 to 65 dB Frequency Cut 1 kHz Blend 1 kHz Coagulation 2 kHz Fulguration 2 kHz Bipolar 2 kHz Duration Continuous while the generator is activated Alarm Tone Volume not adjustable 70 dB 5dB Frequency 2 kHz seconds 1 kHz seconds Duration 25 Low Frequency 50 60 Hz Leakage Current Enclosure source current ground open lt 500 pA Normal polarity intact ground lt 50 pA Source current patient leads all outputs Normal polarity ground open lt 50 pA Reverse polarity ground open lt 50 pA Sink current at high line all inputs lt 50 pA High Frequency RF Leakage Current Bipolar RF leakage current lt 39 m rms Monopolar RF leakage current additional tolerance lt 150 mA rms User s Guide Aaron 950 A 3 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 BF Equipment IEC 60601 1 Defibri
18. ccescsssessecsssssseceseeuseeceeessnusceecenteeseessneescessenssecss Standards and IEC Classifications sssssssssssscsscsessccessssssessessssesscessuseecescesneseeseensussecesnueseeceeesseeceeeennaeess Class Equipment IEC 60601 1 cscssssssscsssscssssssscssssccsssssccssssccsssssccssssccsssusccessusesssusccessnsesssnecseses Type BF Equipment IEC 60601 1 Defibrillator Proof ssssssessccssseessccessnseccescssseessessseesecerseees Drip Proof IEC 6060 1 22 iscrisse ansni ii Electromagnetic Interference scsssssscssssssssssesssssssesssssssessssccssssscssssnscsssuscesssnscsssussessasecsssusccsssvesees Electromagnetic Compatibility IEC 60601 1 2 and IEC 60601 2 2 Voltage Transients Emergency Generator Mains Transfer ssssssccssssssscceesnseccescssseesecssseetecceeeees EMGCompliance a reca ee at QuEput Characteristics os siceccccccesseccssacssssssassoususvesvonssluscasacasazatescoscesseesoessssessssassaabaatasuouaatasharstanatesscccstteeeste Maximum Output for Bipolar and Monopolar MOdeS sssssssssccssseesssssescssssecessesccsssncesssseccsssnceees Output Power CUTVES ir ie Filiere A ILL Monopolar Cut Wives iseinu eiea Monopolar Coag Curves me Bipolar CUIVOS ssissss3secececcessstexssoessnssscansovassnvas cvsssac essecesssccccassconssscsansbSconussuseessossnbsdastonseecacsccovensss ALC UL 5 sin WELL LIL RL Ro ER So B 1 User s Guide Aaron 950 LIST OF FIGURES vi
19. code reappears record the number and contact Bovie Medical Corporation customer service Internal temperature of the unit E3 exceeded limit If the unit displays any other error code it requires service 6 2 Bovie Medical Corporation REPAIR POLICY AND PROCEDURES Refer to this section for information on The Manufacturers Responsibility O Returning the Generator for Service User s Guide Aaron 950 RESPONSIBILITY OF THE MANUFACTURER Bovie Medical Corporation 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 e Persons authorized by Bovie Medical Corporation performed assembly operation readjustments modifications or repairs e The electrical installation of the relevant room complies with local codes and regulatory requirements such as IEC and BSI e Equipment use is in accordance with the Bovie Medical Corporation 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 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 ship it to Bovie Medical Corporation for service Step 1 Obtain a Ret
20. covered with synthetic material the relative humidity should be at least 30 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 Mains power quality should be that of a typical commercial or hospital environment If the user of the Aaron 950 requires continued operation during power mains interruptions it is recommended that the Aaron 950 be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE U is the a c mains voltage prior to application of the test level Bovie Medical Corporation Guidance and manufacturer s declaration electromagnetic immunity continued IEC 60601 Immunity test y test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Aaron 9507M including cables than the Conducted RF 3 Vrms recommended separation distance calculated IEC 61000 4 6 a to 80 from the equation applicable to the frequency of the transmitter Recommended separation distance d 3 51 p Ra d 28v P 1 80 MHz to 800 MHz We 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W accordi
21. cted A When pressed selects the When depressed for 2 seconds F b and d are displayed in lower next preset setting makes the current settings the case letters preset letter shown in the indi cator window No Presets Indicator Dot blinks to indicate when no user defined preset is being used User s Guide Aaron 950 2 5 INDICATORS AND RECEPTACLES Figure 2 4 Indicators and receptacles SOREN IG sm eo me ob ja UJ x Patient Plate Monopolar Alarm Bipolar Footswitch j j j CO VW Monopolar Handpiece Patient Plate Grounding Bipolar Cord Receptacle Footswitch Receptacle Receptacle Receptacle Accepts the Aaron A827EU bipolar Accepts the Aaron A1203W Accepts the Aaron A901 Accepts the Aaron A1202C forceps cord footswitch cord 3 button handpiece cord reusable grounding cord Patient Plate Alarm Indicator Indicates an alarm condition regard ing the patient return cord or pad 2 6 Bovie Medical Corporation REAR AND SIDE PANELS Figure 2 5 Layout of controls and indicators on the rear and side panels a T C i i HEH si gi da gs ge gs 8s 3 st al pe z Symbols on the Rear Panel SYMBOLS DESCRIPTION V Cp amp Volume control Fuse enclosed Read Instructions Before Use Do not dispose of this device in the unsorted municipal waste stream Manufacturer NOTICE Pleas
22. d hazards of using electrosurgery in that procedure To promote the safe use of the Aaron 950 Electrosurgical Generator this section presents the warnings and cautions that appear throughout this user s guide So that you can operate this equipment with maximum safety it is important that you read understand and follow the instructions in these warnings and cautions It is also important that you read understand and follow the instructions for use in this user s guide WARNINGS Hazardous Electrical Output This equipment is for use only by trained licensed physicians Danger Fire Explosion Hazard Do not use the Aaron 950 electrosurgical generator in the presence of flammable anesthetics 1 2 Bovie Medical Corporation WARNINGS 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 N50 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 elect
23. e note that infected medical devices must be disposed of as medical biohazard waste and cannot be includ ed 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 Symbols on the Side Panel SYMBOLS 2 DESCRIPTION Non ionizing Radiation O Danger Explosion Risk If Used With Flammable Anesthetics User s Guide Aaron 950 2 8 Bovie Medical Corporation GETTING STARTED This section includes the following information O Initial Inspection O Installing the Unit User s Guide Aaron 950 3 1 INITIAL INSPECTION When you first unpack your Aaron 950 Electrosurgical Generator inspect it visually e 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 Corporation s Customer Service immediately Do not use any damaged equipment INSTALLING THE UNIT 1 Mount the Aaron 950 Electrosurgical Generator on the wall or optional stand using the mounting kit See Figure 3 1 CAUTION The unit is not to be utilized in the horizontal position as liquids may easily spill into the unit If mounting on a wall surface a qualified individual should be consulted to avoid damage to the wall surface L N q
24. ent 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 charac teristics that match those listed on the back of the unit Fire Hazard Do not use extension cords Patient Safety Use the generator only if the self test has been completed as described Otherwise inaccurate power outputs may result The instrument receptacles on this generator are designed to accept only one instrument at a time Do not attempt to connect more than one instrument at a time into a given receptacle Doing so will cause simultaneous activation of the instruments Failure of the high frequency electrosurgical equipment could result in an unintended increase of output power Do not use electrosurgical equipment unless properly trained to use it in the specific procedure being undertaken Use by physicians without such training has resulted in serious unintended patient injury including bowel perfora tion 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
25. er control of bleeding in highly vascular tissue over broad surface areas e Presets The unit incorporates six user defined presets for easy recall of frequently used settings e Isolated RF output for Cut Blend and Coag modes This minimizes the potential of alternate site burns e Ground Referenced RF output for Fulguration mode e 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 or Aaron brand accessories supplied with your generator e Aaron 950 Electrosurgical Generator e A901 Handpiece e 50 sharp and 50 blunt non sterile dermal tips e Ten A910 handpiece drapes e Five disposable electrodes 3 blades 1 ball 1 needle e Hospital grade power cord e One reusable grounding cord e Wall mount bracket e Five disposable grounding pads e User s Guide 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 an
26. icator indicates that the unit is not presently set to a user defined preset PREPARING FOR MONOPOLAR SURGERY Cut Blend and Coagulation modes require a patient return electrode Applying the Patient Return Electrode Refer to the manufacturer s instructions for application site and placement procedures When using metal plate patient return electrodes use a conductive gel specifically designed for electrosurgery Select a patient 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 Plug the handpiece into the monopolar output on the lower left of the front of the unit see figure 4 1 letter B The plug is designed to fit in only one direction Plug the smaller round connector from the handpiece into the receptacle on the bottom of the unit The three button handpiece is designed to give the doctor complete fingertip control of the power settings The Aaron A901 handpiece is unique handpieces manufactured by other manufac turers will not function with this unit Do not use the Aaron A901 handpiece on other brand units 2 Slide the desired active electrode into the handpiece until it is firmly seated see figure 4 1 letter M The handpiece will accept most standard 3 32 24 cm electrodes 3 Slide the handpiece from above into the holder on the right side of the unit 4 Plug the male end of
27. 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 e Electrosurgical Generators Two years from date of shipment e Mounting Fixtures all models Two years from date of shipment e Footswitches all models Ninety days from date of shipment e Patient Return Electrodes Shelf life only as stated on packaging e Sterile Single Use Accessories Only as stated on packaging e Handpiece Only as stated on packaging User s Guide Aaron 950 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
28. ions for symbols found on the front panel of the Aaron 950 SYMBOLS DESCRIPTION Generator Controls Cut mode LIL Blend mode dl Coagulation mode High Frequency Desiccator Controls Bipolar mode A Fulguration mode Presets gt Select next preset nf Set new preset Indicators RF ground referenced Defibrillator proof type BF equipment Read instructions before use Caution high voltage we gt m p H RF Isolated patient connections are isolated from earth at high frequency Handpiece Connectors ma E Monopolar handpiece Patient return electrode DA Footswitch Bipolar forceps User s Guide Aaron 950 2 3 CUT BLEND AND COAG CONTROLS Figure 2 2 Controls for the cut blend and coag modes Power Display watts Indicates the power set for the Cut Indicator Cut Blend Active Indicator selected mode Cut Mode Selector Indicates when pure Indicates that the power When pressed selects cut mode is selected has been activated in the selected the pure cut mode mode FREQUENCY DESICC Blend Mode Selector When pressed selects the blended cut mode cei Coag Fulguration Bipolar Active Active Indicator Indicates that the power has been activated in the selected mode Power Control Blend Indicator gt aS Indicates when ne A cut mode is selected Pa D RF Isolated Indicator Indicates when the i
29. irsier i ea n A EEEE NEA 6 1 Repair Policy and Procedures c sssssesssssssssssssssssssnssessosnsssessesnsenssnssessvesvsbesneessssnssussosnestssnsenstassnsesssostesees 7 1 Responsibility of the Manufacturer ssssssccsscsssccescssseessssssssesceseeueesccseessuscescsnseesecesunesseceeeesnseeesennesess 7 2 Returning the Generator for Service c s sssscssssssscssssccsssssscssssccsssssscssseccsssssccssssccsssusccsssscesssusccessseesssnsessees 7 2 Step 1 Obtain a Returned Goods Authorization NUMDET sssccssssessssesscssssecsssseccsssseessseeesesees 7 2 Step 2 Clean the Generator ccscssssssssssssssssssscssssscsssvescssssscssssssccsssscessnescsssasesssvescessnsesssveseessnses 7 2 Step 3 Ship the GeneratOr sscccsssesccssassssssssccssascssssescesssecsssssssessssscssvescessssscssvsscessseesesvseesenses 7 2 iv Bovie Medical Corporation Technical SpecificationS soscerer Performance Characteristics IPU POWOE sossssssasaescccesscossscsansaconssadbansvveasvvadeassstansescscousscocoscssTessazssasasiivanaivuuaavaastanaaneaeesteccnnsnsianectes DU y CV CLs E E E O E E Dimensions and Weight ss ics ssseccccssnssssavtovassavascecssssscasteconseccocnvavtcsdsccsssuuSSesuvasvnsubvoesssdddddauosttecccsstens Operating Palameters i aa a LEI ENO PR A AN ed Aldio VolUme cicala Low Frequency 50 60 Hz Leakage Current High Frequency RF Leakage Current ssssccsssssse
30. llator Proof i The Aaron 950 Electrosurgical Generator provides a high degree of protection against electric shock J E particularly regarding allowable leakage currents It is type BF equipment Patient connections are isolated from earth and resist the effects of defibrillator discharge Drip Proof IEC 60601 2 2 The generator enclosure is constructed so that liquid spillage in normal use does not wet electrical insulation or other components which when wet are likely to affect adversely the safety of the generator Flectromagnetic Interference When other equipment is placed on or beneath an activated Bovie Medical Corporation electrosurgical generator the Aaron 950 Electrosurgical Generator operates without interference The generator minimizes electromagnetic inter ference to video equipment used in the operating room Electromagnetic Compatibility IEC 60601 1 2 and IEC 60601 2 2 The Aaron 950 Electrosurgical Generator 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 950 Electrosurgical Generator operates in a safe manner when the transfer is made between line AC and an emergency generator voltage source EMC COMPLIANCE Special precautions should be taken regarding the Aaron 950 Medical Electrical Equipment needs special precau tions regarding EMC and needs to be installed and put i
31. monitors An activated electrosurgical generator may cause interference with them 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 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 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 clea
32. n dry nonconductive 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 1 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 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 Bovie Medical Corporation Ye ers EE o OIG rito in CONTROLS INDICATORS AND RECEPTACLES This section describes The Front Rear and Side Panels O Controls Indicators and Receptacles User s Guide Aaron 950 2 1 FRONT PANEL Figure 2 1 Layout of controls indicators and receptacles on the front panel 950 HIGH FREQUENCY DESICCATOR Fulguration Active O i Bipolar Power Control o E Presets A Recall Set Ee SO x RE Patient Plate U Monopolar Alarm Bipolar Footswitch 4 7 4 2 2 Bovie Medical Corporation Symbols on the Front Panel The following table lists descript
33. ng to the 3 V m transmitter manufacturer and d is the Radiated RF 80 MHz to recommended separation distance in metres 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 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 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 950 is used exceeds the applicable RF compliance level above the Aaron 950 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Aaron 950 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than V V m User s Guide
34. nto 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 950 The Aaron 950 and its accessories are not suitable for interconnection with other equipment Portable and mobile RF communications equipment can affect Medical Electrical Equipment The Aaron 950 should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the Aaron 950 should be observed to verify normal operation in the configuration in which it will be used A 4 Bovie Medical Corporation Recommended separation distances between portable and mobile RF communications equipment and the Aaron 950 The Aaron 950 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Aaron 950 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Aaron 950 as recommended below accord ing to the maximum output power of the communications equipment Rated maximum output separation distance according to frequency of transmitter Powerot ransmitter 150 kHz to 80 MHz 80 MHz to 800 MH
35. ous 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 950 iii TABLE OF CONTENTS Equipment Covered in this Manual For Information Call Conventions Used in this Guide e ssssssssssccsssessscssssnsseccsssssessessssussecessusseecescassseceecnnussscesnsesseceeesnseeceeenneess iii Introducing the Aaron 950 Electrosurgical Generator sssscsscscsscsssssssssssssssesstessesssscsssscesssesseeens 1 1 Key Fea tires eongo Components and Accessories ATOMI IL EE TIN RET OTE EE Controls Indicators and Receptacles sesessssessesssssssesssscsssccsssccessscessecessscoeessccessecossecessecessscesseeessseess 2 1 Front Pan li rca la adele 2 2 Syimbols onithe Front PaN l EA aaa 2 3 Cut Blend and Coag Controls cc csssssscsssscsssssssssssscsssssscssssscessssecesssccsssssscesssscsssssscesusccsssuscessuecesssusceesssees 2 4 Fulguration Bipolar and Preset COntrols sssssssssscssssssscssssccssssecsssscccssssscssssscessssscssssccesssuscesseccessseseesees 2 5 Indicators and Receptacles c c sssccsssssscsssssssssssscssesessssnssesssscsssssscessssscsssuscesssscessssecssvsseesssuscessesessssesce
36. r versus impedance for coagulation MOdE ssscsssescsssescsssseccsssescsssseecssseecesssees A 11 Figure A 6 Peak voltage versus power setting for coagulation mode ssssssescsssesccssseccsssesccssseccesseecesssees A 11 Figure A 7 Output power versus impedance for fulguration mode Figure A 8 Peak voltage versus power setting for fulguration mode Figure A 9 Output power versus impedance for bipolar mode Figure A 10 Peak voltage versus power setting for bipolar MOd sssssccssseccssseecsssseccesseecsssseesssseecesssees Bovie Medical Corporation INTRODUCING THE AARON 950 ELEGTROSURGICAL GENERATOR This section includes the following information O Key Features O Components and Accessories O Safety CAUTIONS Read all warnings cautions and instructions provided with this generator before using Read the instructions warnings and cautions provided with electrosurgical accessories before using Specific instruc tions are not included in this manual User s Guide Aaron 950 1 1 KEY FEATURES The Aaron 950 Electrosurgical Generator includes the latest technology This unit offers unsurpassed performance flexibility reliability and convenience It includes the following features e Two levels of coagulation Pinpoint Coagulation and Fulguration Pinpoint Coagulation provides precise control of bleeding in localized areas Fulguration provides great
37. rcase e The power display will show the power level for the last used Preset setting e The mode for the last activated Preset setting is selected If the self test is not successful an alarm tone sounds An error code may appear on the power 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 950 USING AND UNDERSTANDING THE AARON 950 MEMORY FEATURES The Aaron 950 incorporates six user defined Presets for easy recall of frequently used settings Storing and Recalling Preset Settings Select the desired preset location A F by pressing the Recall button see figure 4 1 letter H Select the desired mode to be stored by pressing one of the mode membrane switches see figure 4 1 letter A Select the desired power to be stored by utilizing the power output control knob see figure 4 1 letter J Once all the settings are selected depress and hold the Presets Set Button see figure 4 1 letter for 2 seconds To indicate the settings have been stored the letter on the Presets indicator will blink To recall a preset simply press the Presets Recall button to toggle through all the presets NOTICE A small dot blinking in the lower left corner of the Presets ind
38. red position 3 To activate the unit depress the activation button on the handpiece see figure 4 1 letter L or depress the pedal on the footswitch While the unit is activated the appropriate audible tone is sounded and one of the activation LEDs will illuminate see figure 4 1 letter N 4 When the procedure is completed turn the unit off 5 Return the handpiece to the holder on the right side of the unit and remove the electrode The electrode should be disposed of after each procedure If contamination has occurred to the handpiece the handpiece should be sterilized NOTICE When sterilizing the handpiece follow the manufacturer sterilization instructions that accompany the handpiece Bipolar Activation 1 If the unit is not already set up follow the set up procedure to prepare the unit for operation 2 Place the forceps in the desired position 3 To activate the unit depress the footswitch pedal While the unit is activated an audible tone is sounded and the blue activation LED will illuminate see figure 4 1 letter N 4 When the procedure is completed turn the unit off 5 Remove the forceps from the bipolar cord and sterilize NOTICE When sterilizing the forceps follow the manufactures sterilization instructions that accompany the forceps User s Guide Aaron 950 4 7 Figure 4 1 Setup procedures 4 8 LI gt Footswiteh N Bovie Medical Corporation MAINTAINING THE AARON 950
39. rosurgery is performed Connect the power cord to a properly polarized and grounded power source with the frequency and voltage charac teristics that match those listed on the back of the unit Electric Shock Hazard Connect the generator power cord to a properly grounded receptacle Do not use power plug adapters Electric Shock Hazard Always turn off and unplug the generator before cleaning Fire Hazard Do not use extension cords Patient Safety Use the generator only if the self test has been completed as described Otherwise inaccurate power outputs may result Failure of the high frequency electrosurgical equipment could result in an unintended increase of output power The instrument receptacles on this generator are designed to accept only one instrument at a time Do not attempt to connect more than one instrument at a time into a given receptacle Doing so will cause simultaneous activation of the instruments Use the lowest output setting necessary to achieve the desired surgical effect Use the active electrode only for the minimum time necessary in order to lessen the possibility of unintended burn injury Pediatric applications and or procedures performed on small anatomic structures may require reduced power settings The higher the current flow and the longer the current is applied the greater the possibility of unintended thermal damage to tissue especially during use on small structures
40. rovide 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 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 dis tance from the generator and set the generator volume control at a level that ensures that the activation tones can be heard NOTICES If required by local codes connect the generator to the hospital equalization connector with an equipotential cable Connect the power cord to a wall outlet having the correct voltage Otherwise product damage may result SETTING UP 1 If the unit is not already installed refer to Section 3 of this manual for the installation procedure 2 Turn on the generator by pressing the power switch ON see figure 4 1 letter G Figure 4 1 is located at the end of this Section Verify the following All visual indicators and displays on the front panel illuminate e Activation tones sound to verify that the speaker is working properly 3 If the self test is successful a tone sounds Verify the following e The unit resets to the last activated Preset setting The Preset display will display a letter from A F Preset letters b and d will display in lowe
41. s Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 User s Guide Aaron 950 A 5 A 6 Guidance and manufacturer s declaration electromagnetic immunity The Aaron 950 is intended for use in the electromagnetic environment listed below The customer or the user of the Aaron 950 should assure that it is used in such an environment L Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power sup ply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 6 kV contact 8 KV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 U lt 95 dip in U for 0 5 cycle lt 40 U lt 60 dip in U for 5 cycles 70 U lt 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec 2 kV for power supply lines 1 KV for input output lines 1 kV differential mode 2 kV common lt 5 U lt 95 dip in U for 0 5 cycle lt 40 U lt 60 dip in U for 5 cycles 70 U lt 30 dip in U for 25 cycles lt 5 U gt 95 dip in U for 5 sec Floors should be wood concrete or ceramic tile If floors are
42. sees 2 6 Rear and Side Panels sna ra lA ioni 2 7 Symbols on the Rear Panel sssvsssssssvssecsessvsseceessssnsceessnnvssecsessssesoeesenseccegesssvussesnsvaneseegsvaseceerenses 2 7 Symbols on the Side Pattel ssasvscaveesesedsacceeccescbevssarsnavaebebenstuevsdnutceesenvneuecccuareu tabvnooamaatates 2 7 Getting Started ss creare 3 1 pitia MPE iniii i i i eA NR 3 2 Installing the Unitn IAA aaa 3 2 Using the Aar n 950 inniinn aan Inspecting the Generator and Accessories Setup Safety essssesssssesseesosseresseosssneoessresseres SettingiUp ar o a i i EEOAE OAE OE E Using and Understanding The Aaron 950 Memory Features ssscssssssessecssssssscccecseecceseesneecesesnneeseeees 4 4 Storing and Recalling Preset SettingS ssssssssssccssssecssseccsssseesssssscsssssscssssccesssesessueccessseeessneccessneseet 4 4 Preparing for MONOpolar Surgery sscsssessscccsssseecesscsssessssssussscesssueeceesssseceesssnssseecsntsetseseesueceeeeaneeeseceet 4 4 Applying the Patient Return Electrode essccsssssseccescsssesccesssesscccscsnscceeessnssscsesnnesseceeeaseeceesenneeess 4 4 Preparing for Bipolat SUrgeryi uranio iaia 4 5 Activation Safety Rien 4 6 Activating he Unit ereraa a an NOE cena 4 7 Mo opolar Activation PER iiinn n ed 4 7 Bipolar Activatie ineen a e eri 4 7 Maintaining the Aaron 950 Cleaning Periodic Inspectioni z azia rei OA Na Tro bleshootin g
43. t of the output power Power output is dis played in one watt increments for Cut Blend and Coagulation mode The maximum power for each of these modes is 60 watts Power is displayed in 1 watt increments below ten watts and in whole numbers from ten to 35 watts NOTICE The output settings cannot be adjusted when the unit is being activated 8 The unit is now ready to perform surgery Refer to Activating the Unit later in this section PREPARING FOR BIPOLAR SURGERY 1 Insert the two connectors from the bipolar cable into the bipolar cord receptacles see figure 4 1 letter D 2 Connect the desired forcep to the operating end of the bipolar cord 3 Plug the footswitch cable into the footswitch jack see figure 4 1 letter E A footswitch is required to activate the Bipolar mode NOTICE Dispersive electrodes are not utilized during bipolar procedures 4 Select the Bipolar mode by pressing the membrane switch on the front of the unit see figure 4 1 letter A 5 Set the output power either by using the dial on the front of the unit see figure 4 1 letter J or by the up and down but tons on the handpiece see figure 4 1 letter K When power level adjustment is being made by the handpiece an audible tone will sound to indicate that the power level has been changed Depressing and holding the up or down buttons will cause the power settings to change more rapidly for quick adjustment of the output power Power is displayed
44. 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 genera tors Interference produced by the use of electrosurgical devices can cause devices such as pacemakers to enter an asynchronous mode or can block the pacemaker effect entirely Consult the device manufacturer or hospital Cardiology Department for further information when use of electrosurgical appliances is planned for patients with cardiac pacemakers or other implantable devices CAUTIONS The use of high frequency current can interfere with the function of other electromagnetic equipment When high frequency surgical equipment and physiological monitoring equipment are used simultaneously on the same patient place any monitoring electrodes as far as possible from the surgical electrodes Monitoring systems incorporating high frequency current limiting devices are recommended Do not use needles as monitoring electrodes during electrosurgical procedures Inadvertent electrosurgical burns may
45. to the address given to you by the Bovie Medical Corporation Service Center 7 2 Bovie Medical Corporation TECHNICAL SPEGIFICATIONS 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 950 A 1 PERFORMANCE CHARACTERISTICS Input Power 120 VAC 10 220 VAC 10 Mains line frequency 50 60 Hz Mains line frequency 50 60 Hz Power consumption 240 VA Power consumption 240 VA Fuses two 2 0 A Slow Blow Fuses two 1 0 A Slow Blow Duty Cycle Under maximum power settings and rated load conditions Pure Cut 60 watt 500 Q load the generator is suitable for activation times of 10 seconds on 30 seconds off for one hour Dimensions and Weight Width 26 cm 10 25 in Depth 11 4 cm 4 5 in Height 17 8 cm 7 0 in Weight lt 3 2 kg lt 7 lbs Operating Parameters Ambient temperature range 10 to 40 C Relative humidity 30 to 75 non condensing Atmospheric pressure 70kPa to 106kPa Warm up time If transported or stored at temperatures outside the operating temperature range allow one hour for the generator to reach room temperature before use Transport and Storage Ambient temperature range 40 to 70 C Relative humidity 10 to 100 including condens
46. urned 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 e Hospital clinic name customer number e Telephone number e Department address city state and zip code e Model number e Serial number e Description of the problem e Type of repair to be done 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 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 Package it in its original shipping container if available C Ship the generator prepaid
47. z 800 MHz to 2 5 GHz e NE Ww 0 12 0 12 0 23 0 38 0 38 0 73 1 2 1 2 2 3 3 8 3 8 7 3 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance 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 950 is intended for use in the electromagnetic environment listed below The customer or the user of the Aaron 950 should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance The Aaron 950 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 9507Mis suitable for use in all establishments other than domestic and those directly Class A connected to the public low voltage power supply net work that supplies buildings used Complies in domestic purpose

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