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Aaron 1250 (A1250U) User Guide

1. ssssseseeseenetete tette 4 5 Activation Safety zh asia io Stone at to redibat est a A bad cd det 4 6 Activatirig the Urt x i e eene arp Pr tee neon 4 7 Maintaining the Aaron 12507 ssssscssssssssesssesssssseesssssesseessessseseeesseesseseesseeseecenesseeseeeeeessneas 5 1 Cleanilig 5e oc eco er tee dte t o o eee i ci tare 5 2 Periodic Irispectiori 55 eh trenta temp hn rn n ER ERH 5 2 Fuse Replaceimient su c eode eoe e b bed ab ebbe t pe bead 5 2 Troubleshooting AA A tte tete tse anota sta snas 6 1 iv Bovie Medical Corporation Repair Policy and Procedures eene nennen tnnt teretes Responsibility of the Manufacturer Returning the Generator for Service Step 1 Obtain a Returned Goods Authorization Number 7 2 Step 2 Clean the Generator sse tentent 7 2 Step 3 Ship the Generator tette tenentes 7 2 Technical Specifications essere trente treten tentnn tentent A 1 Performance Characteristics sse nennen tentent A 2 MDOE POWE s nih osito ido t tcd co added dtf enun A 2 Duty Cycle 3nd cbe edem bie te b neas A 2 Dimensions and Weight umu 2 ttai epe qoid pce pete A 2 Operating Parameters sssssseeeeetente tentent tnnt tentent A 2 Transport 2o patete teo bet A dedo peso iod A 2 Storage sisean aee ops t
2. AARON 1250 User s Guide g e MM AARON 1250 ELECTROSURGICAL GENERATOR o Q9 Cut Q Coagulation ye c o Blend JE Fulguration 75 Biplar Return Electrode Foot Control 9 Power Qo Alarm o eo Monopolar Bipolar Foot Control Monopolar Bipolar Z AO T Return Electrode qe User s Guide Aaron 1250 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 1250 Electrosurgical Generator only Additional technical information is available in the Aaron 12507 Electrosurgical Generator Service Manual For the latest user information and technical bulletins visit www boviemed com Equipment Covered in this Manual Aaron 1250 Electrosurgical Generator Model No A1250U For Information Call Bovie Medical Corporation 5115 Ulmerton Road Clearwater Florida 33760 USA U S Phone 1 800 537 2790 Fax 1 800 323 1640 International Phone 1 727 384 2323 Fax 1 727 347 9144 www boviemed com sales boviemed com Ec REP Emergo Europe C E 0413 molenstraat 15 2513 BH The Hague The Netherlands 2013 Bovie Medical Corporation All rights reserved Contents of this publication may not be reproduced without the written permission
3. Minor neuromuscular stimulation is possible when arcs between the ACTIVE ELECTRODE and tissue occur The generator has been designed to minimize the possibility of neuromuscular stimulation Danger Fire Explosion Hazard Do not use the Aaron 1250 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 e Oxidizing agents such as nitrous oxide NO 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 elec trode 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 d
4. Verify that the unit is connected to the line voltage Line voltage too high 3 If the error code reappears record the number and contact Bovie customer service 1 Turn the unit off 2 Allow the unit to cool for 20 minutes Internal temperature of a section of a the unit exceeded the limit dr IUD DIS MCN 4 If the error code reappears record the number and contact Bovie customer service 1 If this cable becomes disconnected an E8 error shall occur and be Connector Sense Error The unit shall monitor the connec displayed E8 2 The unit cannot be activated while the error condition is present tion of the main cable between the f 3 The unit has to be reset to remove the error condition main and display boards NOTICE If the unit does not power on to display an error check fuses as described in Section 5 of this guide 6 2 Bovie Medical Corporation REPAIR POLICY AND PROCEDURES Refer to this section for information on o Responsibility of the Manufacturer o Returning the Generator for Service User s Guide Aaron 12507 7 1 RESPONSIBILITY OF THE MANUFACTURER Bovie Medical Corporation is responsible for the safety reliability and performance of the generator only under the following circumstances The user has followed the Installation and Setup Procedures in this User s Guide Persons authorized by Bovie Medical performed assembly operation readjustments modifications or repairs
5. The electrical installation of the relevant room complies with local codes and regulatory requirements Equipment use is in accordance with the Bovie Medical instructions for use For warranty information refer to Appendix B Warranty RETURNING THE GENERATOR FOR SERVICE Before you return the generator call your Bovie Medical representative for assistance If instructed to send the generator to Bovie Medical Corporation first obtain a Returned Goods Authorization Number Then clean the Generator and package securely to ensure proper protection of the unit So as to aid in the processing of the unit please be sure to include a reference to the Return Goods Authorization Number on the outside of the box and ship directly to Bovie Medical Corporation Step 1 Obtain a Returned Goods Authorization Number Call the Bovie Medical Corporation Customer Service Center to obtain a Returned Goods Authorization Number Have the following information ready when you call Hospital clinic name customer number Description of the problem Telephone number fax number Type of repair to be done Department address city state and zip code P O number Model number Serial number Step 2 Clean the Generator 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
6. and Bipolar Controls i cit ei up UR ette e re pattes 2 5 IridICatOrS c rte E titi eu HERR A PE UE RE RUPES 2 6 Power Switch and Receptacles sse ntes 2 7 Hear Pariel selben etc N edlen eani eignen abi opis 2 8 Symbols on the Rear Panel uie easet tdt ter pd 2 8 Gettinig Started once ceca IM c eM EE M ibet cand 3 1 Initial niSDeCtlori c t terret re ehe ones 3 2 Iristallatioriz i uio iti esf tte Made Metodo ade tto dpt teo dd be eode 3 2 Fu nction Ghecks 2 Gn ein ee tani a bett han edente diede 3 2 Setting Up the Unit s d e Rue pb E ede pd 3 2 Checking the Return Electrode Alarm sees 3 2 Gonfitming Mod s aot t TA tte te be tdi dated al uet ied 3 3 Checking Bipolar Mode with footswitch eee 3 3 Checking Monopolar Mode with footswitch ene 3 3 Checking Monopolar Mode with handswitch eee 3 3 Performance Checks 1 oni toot dod hber edd p pads 3 8 Using the Aaron 1250 ue essent tenter ANAKARA 4 1 Inspecting the Generator and Accessories sssseeneees 4 2 SISTI MEE E 4 2 Setting pz steer patina e ee ei 4 4 Preparing for Monopolar Surgery sssssseeeeenete tentent 4 5 Applying the Return Electrode ssennenennnnnnn 4 5 Connecting ACCeSSOTIGS ier ERG n tret ei praec t ree eden i e 4 5 Preparing for Bipolar Surgery
7. enter an asynchronous mode or can block the pacemaker effect entirely Consult the device manufacturer or hospital Cardiology Department for further information when use of electrosurgical appliances is planned for patients with cardiac pacemakers or other implantable devices If the patient has an Implantable Cardioverter Defibrillator ICD contact the ICD manufacturer for instructions before performing an electrosurgical procedure Electrosurgery may cause multiple activation of ICDs The entire area of the neutral electrode should be reliably attached to the patient s body and as close to operating field as possible Refer to instructions for use The PATIENT should not come into contact with metal parts which are earthed or which have an appreciable capacitance to earth for example operating table supports etc 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 When HF SURGICAL EQUIPMENT and physiological monitoring equipment are used simultane ously on the same PATIENT any monitoring electrodes should be placed as far as possible from
8. footcontrol by pressing the Footswitch Control selector until the Monopolar Footswitch Control indicator illuminates 2 Connect a single plate return electrode to the return electrode receptacle Verify that the green single plate return electrode indicator illuminates 3 Press the Cut pedal yellow on the footswitch Verify that the Cut and Blend mode activation indicator illuminates and that the system generates the Cut activation tone 4 While activating the Cut mode rotate the volume control over the full range to verify that the sound is audible throughout the range 5 Press the Coag pedal blue on the footswitch Verify that the Coag Fulguration and Bipolar activation indicator illuminates and that the system generates the Coag activation tone 6 While activating the Coag mode rotate the volume control over the full range to verify that the sound is audible throughout the range Checking Monopolar Mode with handswitch 1 Connect a handswitching handpiece to the Monopolar handpiece receptacle 2 Activate one at a time the Cut and Coag handswitching controls Verify that each control causes the correct indicator and tone to sound PERFORMANCE CHECKS After the unit has passed the preliminary functional test it is ready for performance testing qualified biomedical engineer who is thoroughly familiar with electrosurgical devices should conduct this testing The testing should include checking all modes of operation
9. for proper function and power output User s Guide Aaron 1250 3 3 3 4 Bovie Medical Corporation USING THE AARON 1250 This section contains the following procedures 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 instructions are not included in this manual User s Guide Aaron 1250 2j INSPECTING THE GENERATOR AND ACCESSORIES Before each use of the Aaron 1250 verify that the unit and all accessories are in good working order nspect for damage to the Electrosurgical Generator and all its connections Verify that the appropriate accessories and adapters are present nspect 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 liste
10. ims Monopolar RF leakage current additional tolerance lt 150 MA ms Operating Conditions RF energy is generated and passed through an interconnecting cable to an accessory where the energy is delivered to cut coagulate and ablate tissue STANDARDS AND IEC CLASSIFICATIONS Class Equipment IEC 60601 1 Accessible conductive parts cannot become live in the event of a basic insulation failure because of the way in which they are connected to the protective earth conductor Type BF Equipment IEC 60601 1 Defibrillator Proof J L The Aaron 1250 Electrosurgical Generator provides a high degree of protection against electric shock particularly regarding allowable leakage currents It is type BF equipment Patient connections are isolated from earth and resist the effects of defibrillator discharge Drip Proof IEC 60601 2 2 The generator enclosure is constructed so that liquid spillage in normal use does not wet electrical insulation or other components which when wet are likely to affect adversely the safety of the generator Electromagnetic Interference When other equipment is placed on or beneath an activated Aaron 1250 Electrosurgical Generator the unit can be activated without interference The generator minimizes electromagnetic interference to video equipment used in the operating room Electromagnetic Compatibility IEC 60601 1 2 and IEC 60601 2 2 The Aaron 1250 Electrosurgical Generatorcomplies with the appro
11. red alarm indicator remains illuminated red This could indicate improper pad placement or a faulty NEM contact quality monitor circuit 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 Accessories must be connected to the proper receptacle type In particular bipolar accessories must be connected to the Bipolar Instrument output jack only Improper connection may result in inadvertent generator activation 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 evacuator or other means Bovie Medical Corporation 1 U S Department of Health and Human Services National Institute for Occupational Safety and Hea
12. the system detects a split plate is properly placed on the patient 2 6 Monopolar Footswitch Control Indicator Illuminates when monopolar footswitch control is selected Return Electrode OO C C Alarm Single Plate Patient Return Electrode Indicator Illuminates green when the system detects a single plate NOTICE Solid pad indicator only detects that a pad is connected to the unit The unit does not monitor pad placement on the patient Patient Return Electrode Alarm Indicator Illuminates when the system detects a patient retum electrode alarm condition O Monopolar Bipolar Footswitch Control Indicator Illuminates when bipolar footswitch control is Selected Foot Control N Bipolar Footswitch Control Selector When pressed toggles between monopolar and bipolar foot control Bovie Medical Corporation POWER SWITCH AND RECEPTACLES Figure 2 5 Location of the unit power switch and front panel receptacles Patient Return Electrode Monopolar Handswitching Receptacle Receptacle Accepts standard three pin handpieces Accepts a standard patient Connect handswitching accessories return electrode plug B Bipol Return Electrode e oot Control polar Z A Power On Off Switch Monopolar Footswitching Receptacle Bipolar Receptacle Turns the unit on or off Accepts cables or adapters equipped Accepts standard cables with standard Bovie 12 active plugs for bipolar handpieces Conn
13. the surgical electrodes In all cases monitoring systems incorporating HIGH FREQUENCY current limiting devices are recommended 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 n addition place patient return electrodes according to the manufacturer s instructions Potential for alternate site burns increases if the return electrode is compromised Bovie Medical recommends the use of split patient return electrodes and Bovie Medical generators with a contact quality monitoring system Do not wrap the accessory cords or patient return electrode cords around metal objects This may induce currents that could lead to shocks fires or injury to the patient or surgical team The PATIENT leads should be positioned in such a way that contact with the PATIENT or other leads is avoided Minor neuromuscular stimulation is possible when arcs between the ACTIVE ELECTRODE and tissue occur The generator has been designed to minimize the possibility of neuromuscular stimulation Accessories must be connected to the proper receptacle type In pa
14. 4 Figure 2 3 Controls for the Coagulation Fulguration and Bipolar Modes 2 5 Figure 2 4 Indicators for power return electrodes and footswitch control 2 6 Figure 2 5 Location of the unit power switch and front panel receptacles 2 7 Figure 2 6 Layout of connectors and controls on the rear panel 2 8 Figure S 1 Fuse holder ce cnin eter retener 5 2 Figure A 1 Output voltage Vpeak versus power setting Cut Coag A 9 Figure A 2 Output voltage Vpeak versus power setting Bipolar A 9 Figure A 3 Output power versus power setting for all modes ss A 10 Figure A 4 Output power vs impedance for Cut mode ssssss A 10 Figure A 5 Output power vs impedance for Blend mode sss A 11 Figure A 6 Output power versus impedance for Coagulation mode A 11 Figure A 7 Output power versus impedance for Fulguration mode A 12 Figure A 8 Output power vs impedance for Bipolar mode sss A 12 Bovie Medical Corporation INTRODUCING THE AARON 1250 ELECTROSURGICAL GENERATOR This section includes the following information o o Indications for Use Operating Principles Intended Use Key Features Components and Accessories Safety Contraindications Applicati
15. A burn could result Do not stack equipment on top of the generator or place the generator on top of electrical equipment These configurations are unstable and or do not allow adequate cooling Provide as much distance as possible between the electrosurgical generator and other electronic equipment such as monitors An activated electrosurgical generator may cause interference with them Nonfunction of the generator may cause interruption of surgery A backup generator should be available for use Do not turn the activation tone down to an inaudible level The activation tone alerts the surgical team when an accessory is active When using a smoke evacuator in conjunction with the electrosurgical generator place the smoke evacuator a distance from the generator and set the generator volume control at a level that ensures that the activation tones can be heard The use of high frequency current can interfere with the function of other electromagnetic equipment When high frequency surgical equipment and physiological monitoring equipment are used simultaneously on the same patient place any monitoring electrodes as far as possible from the surgical electrodes Do not use needles as monitoring electrodes during electrosurgical procedures Inadvertent electrosurgical burns may result To avoid the possibility of 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
16. C 61000 4 4 Mains power quality should be that of a typical commercial or hospital environment b 96 U b 96 U gt 95 dip in U gt 95 dip in U for 0 5 cycle for 0 5 cycle Mains power quality should be that 40 U 40 U of a typical commercial or hospital Voltage dips short 60 dip in U 60 dip in U for environment f the user of the interruptions and voltage A1250 requires continued variations on power supply operation during power mains input lines 70 96 U 70 Us interruptions it is recommended IEC 61000 4 11 30 dip in U 30 dip in U for that the A1250 be powered from for 25 cycles 25 cycles an uninterruptible power supply or a battery for 5 cycles 5 cycles lt 5 U lt 5 U gt 95 dip in U gt 95 dip in U 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 Uj 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 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part T Vims of the iit including poer ges ib onducte recommen
17. ER SETTING vs MAX VOLTAGE Vpeak VOLTAGE Vpeak 8 8 o 10 20 30 40 50 60 70 B0 90 100 10 120 Figure A 2 Output voltage Vpeak versus power setting Bipolar POWER SETTING vs MAX VOLTAGE Vpeak 1200 VOLTAGE Vpeak 8 8 8 9 5 10 15 20 25 30 POWER SETTING W User s Guide Aaron 1250 A 9 Figure A 3 Output power versus power setting for all modes Output Power vs Power Setting at Rated Load 8 Output Power W 20 30 40 50 60 70 80 90 100 110 120 Power Setting of Total Power Figure A 4 Output power vs impedance for Cut mode CUT MODE s 8 3 4 B eo N o 1500 LOAD OHMS A 10 Bovie Medical Corporation Figure A 5 Output power vs impedance for Blend mode BLEND MODE 1500 LOAD OHMS Figure A 6 Output power versus impedance for Coagulation modes COAGULATION MODE LOAD OHMS User s Guide Aaron 12507 A 11 Figure A 7 Output power versus impedance for Fulguration mode A1250 FULGURATION 1500 2000 LOAD OHMS Figure A 8 Output power vs impedance for Bipolar mode BIPOLAR MODE 750 LOAD OHMS 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 replac
18. accumulation or pooling under surgical drapes or within the area where electrosurgery is performed The use of flammable anesthetics or oxidizing gases such as nitrous oxide N2O and oxygen should be avoided if a surgical procedure is carried out in the region of the thorax or the head unless these agents are sucked away Non flammable agents should be used for cleaning and disinfection wherever possible Flammable agents used for cleaning or disinfecting or as solvents of adhesives should be allowed to evaporate before the application if HF surgery There is a risk of pooling flammable solutions under the patient or in body depressions such as the umbilicus and in body cavities such as the vagina Any fluids pooled in these areas should be mopped up before H F surgical User s Guide Aaron 12507 1 3 1 4 equipment is used Attention should be called to the danger of ignition of endogenous gases Some materials for example cotton wool and gauze when saturated with oxygen may be ignited by sparks produced in Normal Use of the HF surgical equipment No modification of this equipment is allowed Electric Shock Hazard 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 Do not use power plug adapters To avoid risk of electric shock this equipment must only be connected to a supply mains with protective
19. al Corporation If the patient has an Implantable Cardioverter Defibrillator ICD contact the ICD manufacturer for instructions before performing an electrosurgical procedure Electrosurgery may cause multiple activation of ICDs Do not use electrosurgical equipment unless properly trained to use it in the specific procedure being undertaken Use by physicians without such training has resulted in serious unintended patient injury including bowel perforation and unintended irreversible tissue necrosis For surgical procedures where the high frequency current could flow through parts of the body having a relatively small cross sectional area the use of bipolar techniques may be desirable to avoid unwanted coagulation In some circumstances potential exists for alternate site burns at points of skin contact e g between the arm and the side of the body This occurs when electrosurgical current seeks a path to the 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 When HF SURGICAL EQUIPMENT and physiological monitoring equipment are used simultane ously on the same PATIENT any monitoring electrodes should be placed as far as possible from the surgical electrodes In all cases monitoring systems incorporating HIGH FREQUENCY current limiting device
20. al clinical procedure time will not cause a surface skin temperature under the Bovie ESRS or ESRC patient return pads to rise above 41 C when the skin in prepared properly and the pad is attached properly However be aware that extended surgical times particularly at high power will cause a continued temperature rise at the skin and return pad interface due to RF current return to the generator The output power selected should be as low as possible for the intended purpose Certain devices or accessories may present a safety hazard at low power settings Apparent low output or failure of the A1250 RF to function correctly at the normal operating set tings may indicate faulty application of the neutral electrode or poor contact in its connections In this case the application of the neutral electrode and its connections should be checked before selecting a higher output power To avoid incompatibility and unsafe operation use suitable cables accessories active and neutral electrodes including values for the highest allowed H F peak voltage Connected accessories need be rated for at least the maximum peak output voltage of the H F generator set at the intended output control setting in the intended operating mode 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 coagulatio
21. amage 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 The output power selected should be as low as possible for the intended purpose Certain devices or accessories may present a safety hazard at low power settings Apparent low output or failure of the A1250 RF to function correctly at the normal operating set tings may indicate faulty application of the neutral electrode or poor contact in its connections In this case the application of the neutral electrode and its connections should be checked before selecting a higher output power When using Cut mode associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 1250 Vpeak max When using Blend mode associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 1850 Vpeak max When using Coagulation mode associated equipment and active accessories sh
22. ample you select the Blend mode and set the power to 40 watts and select the Bipolar mode and set the power to 10 watts When you turn the unit off it will default to the Cut and Coag modes and their last selected power settings when its turned on again If you then select Blend the power will automatically default to 40 watts since it was your last set power setting Bovie Medical Corporation MAINTAINING THE AARON 1250 This section covers the following topics O Cleaning O Periodic Inspection O Fuse Replacement User s Guide Aaron 1250 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 al
23. applicable RF compliance level above the A1250 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the A1250 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than Va V m User s Guide Aaron 1250 A 7 OUTPUT CHARACTERISTICS Maximum Output for Monopolar and Bipolar Modes Power readouts agree with actual power into rated load to within 2096 or 5 watts whichever is greater Open Circuit Crest Factor Mode Output Power Output Frequency Repetition Rate Vpeak max Rated Load Cut 120 W 500 Q 357 kHz 50 kHz N A 1250V 2 9 20 Blend 90 W 800 Q 357 kHz 50 kHz 30 kHz 5 kHz 1850V 3 3 20 Coagulation 80 W 1000 Q 475 kHz 19 kHz 57 kHz 5 kHz 3300V 5 5 20 Fulguration 40 W 1000 Q 410 kHz 50 kHz 25 kHz 5 kHz 3900V 7 7 20 Bipolar 30 W 200 Q 520 kHz 14 kHz 29 kHz 32 kHz 5 kHz 1200V 6 9 20 an indication of a waveform s ability to coagulate bleeders without a cutting effect A 8 Bovie Medical Corporation OUTPUT POWER CURVES Figure A 1 and A 2 illustrates output voltage Vpeak versus power setting Figure A 3 illustrates output power versus power setting for all modes Figures A 4 through A 8 illustrate specific output power delivered to a range of load resistances for each mode Figure A 1 Output voltage Vpeak versus power setting Cut Coag POW
24. d Indicator tiluminates whan Cut and Blend Power Control Dial Increases or decreases the Cut or Blend ides power output in increments of 1 watt NOTICE When selecting the Blend mode the unit defaults to a setting of minimum blend only the first bar is illuminated 2 4 Bovie Medical Corporation COAG AND BIPOLAR CONTROLS Figure 2 3 Controls for the Coagulation Fulguration and Bipolar Modes Coag and Bipolar Power Display watts Indicates the power set for Coag and Bipolar any Coag or Bipolar Mode Activation Indicator Illuminates when you activate Coagulation Fulguration or Bipolar Mode Coagulation Indicator Illuminates when Coagulation Mode Coagulation Selector is selected C When pressed selects the Coagulation Mode Coag Fulguration Indicator Illuminates when Fulguration Mode is selected O Coagulation O Fulguration Fulguration Selector When pressed selects Bipolar the Fulguration Mode is Bipolar Selector When pressed selects Bipolar Indicator Coag and Bipolar Power Control Dial the Bipolar Mode Illuminates when Increases or decreases the Coag or Bipolar Bipolar Mode power output in increments of 1 watt is selected User s Guide Aaron 1250 2 5 INDICATORS Figure 2 4 Indicators for power return electrodes and footswitch control Power Indicator Illuminates when the unit is on Power Split Plate Patient Return Electrode Indicator Illuminates green when
25. d on the back of the unit No modification of this equipment is allowed 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 Use the lowest output setting necessary to achieve the desired surgical effect Use the active elec trode 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 Avoid using power settings that would exceed the highest maximum voltage that is acceptable for each accessory Choose only accessories that will withstand each mode and power setting Use of the RF Electrosurgical Generator at minimal power setting to get the expected clinical effect and for a normal clinical procedure time will not cause a surface skin temperature under the Bovie ESRS or ESRC patient return pads to rise above 41 C when
26. ded separation distance calculate IEC 61000 4 6 ns to80 3 Vrms V from the equation applicable to the frequency of the transmitter Recommended separation distance c Syr SVE 80 MHz to 800 MHz d 7 Wp Z 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 80 MHz to 3 V m E recommended separation distance in metres m 2 5 GHz Radiated RF IEC 61000 4 3 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 29 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 A1250 is used exceeds the
27. dies 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 Accessories must be connected to the proper receptacle type In particular bipolar accessories must be connected to the Bipolar Instrument output jack only Improper connection may result in inadvertent generator activation When not using active accessories place them in a holster or in a clean dry non conductive and highly visible area not in contact with the patient Inadvertent contact with the patient may result in burns 1 U S Department of Health and Human Services National Institute for Occupational Safety and Health NIOSH Control of Smoke from Laser Electric Surgical Procedures HAZARD CONTROLS Publication No 96 128 September 1996 ACTIVATING THE UNIT When you turn on your unit remember this feature e The A1250 automatically powers up to the Cut and Coag modes and their last selected power settings If the Blend Fulguration or Biploar mode is selected the unit will default to that modes last set power setting 1 Monopolar Cut Select t
28. earth 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 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 Failure of the HF SURGICAL EQUIPMENT could result in an unintended increase of output power Use the lowest output setting necessary to achieve the desired surgical effect Use the active elec trode 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 Avoid using power settings that would exceed the highest maximum voltage that is acceptable for each accessory Choose only accessories that will withstand each mode and power setting Use of the RF Electrosurgical Generator at minimal power setting to get the expected clinical effect and for a norm
29. ect footswitching accessories User s Guide Aaron 1250 2 7 REAR PANEL Figure 2 6 Layout of connectors and controls on the rear panel de ped Ch Ass AARON 1250 lo X QUENCY GENERA INPUT CURRENT 4A Koo re isn Tune I SE a alten dum v we now msu a c io USA m E creo SYMBOLS ON THE REAR PANEL Refer to the following table for descriptions of symbols found on the rear panel of the Aaron 1250 SYMBOLS DESCRIPTION vy Equipotential Ground Stud a Non ionizing Radiation Volume Control Danger Explosion Risk If Used With Flammable Anesthetics Fuse Enclosed Do not dispose of this device in the unsorted municipal waste stream Footswitch Input Jack Read Instructions Before Use SGS Certification Mark Conforms to PART 1 ANSI AAMI ES60601 1 2005 C1 2009 A2 2010 A1 2012 CAN CSA C22 2 No 60601 1 08 C2 2011 PART 2 AAMI 60601 2 2 2009 and CAN CSA C22 2 No 60601 2 2 2009 NOTICE k 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 8 Bovie Medical Corporation GETTING STARTED This section includes the following information Initial Inspection O Installation Functio
30. ed RF disturbances are controlled The customer or the user of the A1250 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the A1250 as recommended below according to the maximum output power of the communications equipment Rated maximum output separation distance according to frequency of transmitter in metres m power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 23 P 3 5 7 MP V1 W For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Guidance and manufacturer s declaration electromagnetic emissions he A1250 is intended for use in the electromagnetic environment listed below The customer or the user of the A1250 should assure that is is used in such an environment Emissions test Compliance Electromagnetic environment guidance T
31. een t epi gno E e c RT RD C P G A 2 Audio MolulTi 15 son decet te alta CURE CR litte re pO A RENE PUDE A 3 Return Electrode Sensing ssssseeeenetetennns A 3 Low Frequency 50 60 Hz Leakage Current see A 3 High Frequency RF Leakage Current seen A4 Standards and IEC Classifications sees A 4 Operating Conditions seen nnne tentent tentennenns A 4 Class Equipment IEC 60601 1 senes A 4 Type BF Equipment IEC 60601 1 Defibrillator Proof A 4 Drip Proot IEG 60601 2 2 seansni en tent redet t padece A4 Electromagnetic Interference eene A 4 Electromagnetic Compatibility IEC 60601 1 2 and IEC 60601 2 2 A 4 Voltage Transients Emergency Generator Mains Transfer A 4 EMG Compliance x eoe cea ep e e E Re bun Dalle A 4 Output Characteristics 5 edet uero ed aired A 8 Maximum Output for Monopolar and Bipolar Modes e A 8 Output Power C rVes ce ad enr oed DU ERR ERA A 9 Warranty ed itae b reason ie Pte e B 1 User s Guide Aaron 1250 vi LIST OF FIGURES Figure 2 1 Layout of controls indicators and receptacles on the front panel 2 2 Figure 2 2 Controls for the Cut and Blend Modes sse 2
32. ement at its sole option of any product or part thereof which has been returned to it or its Distributor within the applicable time period shown below after delivery of the product to the original purchaser and which examination discloses to Bovie Medical Corporation s satisfaction that the product is indeed defective This warranty does not apply to any product or part thereof which has been repaired or altered outside Bovie Medical Corporation s factory in a way so as in Bovie Medical Corporation s judgment to affect its stability or reliability or which has been subjected to misuse neglect or accident The warranty periods for Bovie Medical products are as follows Electrosurgical Generators Two years from date of shipment Mounting Fixtures all models Two years from date of shipment Footswitches all models Ninety days from date of shipment Patient Return Electrodes Shelf life only as stated on packaging Sterile Single Use Accessories Only as stated on packaging User s Guide Aaron 1250 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 Med
33. ent return electrode is required for safe operation User s Guide Aaron 12507 4 3 CAUTIONS Do not stack equipment on top of the generator or place the generator on top of electrical equipment These configurations are unstable and or do not allow adequate cooling Provide as much distance as possible between the electrosurgical generator and other electronic equipment such as monitors An activated electrosurgical generator may cause interference with them Non function of the generator may cause interruption of surgery A backup generator should be available for use Do not turn the activation tone down to an inaudible level The activation tone alerts the surgical team when an accessory is active When using a smoke evacuator in conjunction with the electrosurgical generator place the smoke evacuator a distance from the generator and set the generator volume control at a level that ensures that the activation tones can be heard 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 damge may result SETTING UP 1 Verify that the generator is Off by pressing the power switch Off O 2 Place the generator on a stable flat surface such as a table platform or medical cart Carts with conductive wheels are recommended For details refer to the procedures for you
34. er s Guide Aaron 12507 A 1 PERFORMANCE CHARACTERISTICS Input Power 100 240 VAC Mains line frequency range nominal 50 60 Hz Power consumption 540 VA Fuses two 3 15A Slow Blow Duty Cycle Under maximum power settings and rated load conditions Pure Cut 120 watt 500 ohm load the generator is suitable for activation times of 10 seconds on 30 seconds off for one hour The internal temperature of the unit is continuously monitored If the temperature rises above 85 C the alarm will sound and output power will be deactivated Dimensions and Weight Width 26 cm 10 25 in Depth 30 5 cm 12 in Height 15 2 cm 6 in Weight 4 kg 9 lbs Operating Parameters Ambient temperature range 10 to 40 C 50 to 104 F 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 Ambient temperature range 40 to 70 C Relative humidity 10 to 100 including condensation Atmospheric pressure 50kPa to 106kPa Storage Ambient temperature range 10 to 30 C 68 to 86 F Relative humidity 10 to 75 non condensing 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 a
35. erous 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 A1250 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 Hazardous Electrical Output This equipment is for use only by trained licensed physicians Danger Fire Explosion Hazard Do not use the Aaron 12507 electrosurgical generator in the presence of flammable anesthetics Fire Explosion Hazard The following substances will contribute to increased fire and explosion hazards in the operating room Flammable substances such as alcohol based skin prepping agents and tinctures Naturally occurring flammable gases which may accumulate in body cavities such as the bowel Oxygen enriched atmospheres Oxidizing agents such as nitrous oxide 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
36. g angle normal to the display 30 Site of use Site of use Tissue ligament cartilage Patient population Age newborn to geriatric Weight gt 2 5 kg Health no restrictions Nationality no restrictions Patient state alert relaxed maybe sedated possible local anesthesia Patient should not be User Intended User Profile Education Trained physician physicians assistance clinicians No maximum User s Guide Aaron 12507 1 7 Knowledge Minimum o understands electrosurgery and electrosurgical techniques o read and understand supplied User s Guide accompanying document o understands hygiene No maximum Language understanding Languages as specified in the marketing distribution plan Experience Minimum o Some training on techniques or training under surveillance supervision o Other no special experience needed o No maximum Permissible impairments 1 8 Mild reading vision impairment or corrected vision to 20 20 impaired by 40 96 resulting in 60 96 of normal hearing at 500 Hz to 2 kHz Bovie Medical Corporation CONTROLS INDICATORS AND RECEPTACLES This section describes O The Front and Rear Panels O Controls Indicators Receptacles the Fuse Drawer and Ports User s Guide Aaron 1250 2 1 FRONT PANEL Figure 2 1 Layout of controls indicators and receptacles on the front panel Q Coagulation 2i um als iina ill Fulgurati
37. he A1250 must emit electromagnetic energy in order to RF Emissions CISPR 11 perform its intended function Nearby electronic equipment may be affected Ri Emisslons CISPR 11 Glass A The A1250 is suitable for use in all establishments other than Harmonic emissions Class A domestic and those directly con IEC 61000 3 2 nected to the public low voltage power supply network that sup Voltage fluctuations flicker plies buildings used in domestic emissions Complies purposes IEC 61000 3 3 User s Guide Aaron 1250 A 5 Guidance and manufacturer s declaration electromagnetic immunity The A1250 is intended for use in the electromagnetic environment listed below The customer or the user of the A1250 should assure that is is used in such an environment Immunity test d 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 3096 Electrostatic discharge 6 kV contact 6 kV contact ESD IEC 61000 4 2 8 KV air 8 KV air 2 kV for power 2 kV for power supply lines supply lines 1 kV for 1 kV for input out input output lines put lines 2 d differential 1 kV differential Mains power quality should be that Surge IEC 61000 4 5 moge mode of a typical commercial or hospital 2 kV common 2 kV common environment mode Electrical fast transient burst IE
38. he mode of operation for cut Cut or Blend then Select the desired Cut power settings by rotating the Cut and Blend Power Control Dial 2 Monopolar Coag Select the mode of operation for coagulation Coagulation or Fulguration then Select the coagulation power settings by rotating the Coagulation Fulguration and Bipolar Power Control Dial 3 Bipolar Select the mode of operation for Bipolar then select the Bipolar power settings by rotating the Coagulation Fulguration and Bipolar Power Control Dial User s Guide Aaron 12507 4 7 4 Activate the generator by pressing the appropriate button To Activate Monopolar Yellow Button Handswitching Pencil Cut or Blend Modes Yellow Pedal Footswitch l Blue Button Handswitching Pencil Coagulation or Fulguration Modes Blue Pedal Footswitch Bipolar Any Bipolar 4 8 Yellow Cut or Blue Coag Pedal NOTICES One footswitch activates either monopolar or bipolar footswitching accessories The Aaron 1250 Electrosurgical Generator powers up to the Cut and Coag modes and their last set power settings For example you select the Cut mode and set the power to 50 watts When you turn the unit off it will default to Cut mode at 50 watts when its turned on again The Coagulation mode will also default to the last set power setting For the Blend Fulguration or Biploar modes and power settings the unit will remember the last set power once the mode is again selected For ex
39. ical s products Notwithstanding any other provision herein or in any other document or communication Bovie Medical Corporation s liability with respect to this agreement and products sold hereunder shall be limited to the aggregate purchase price for the goods sold by Bovie Medical Corporation to the customer Bovie Medical Corporation disclaims any liability hereunder or elsewhere in connection with the sale of this product for indirect or consequential damages This warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the State of Florida USA The sole forum for resolving disputes arising under or relating in any way to this warranty is the District Court of the County of Pinellas State of Florida USA Bovie Medical Corporation its dealers and representatives reserve the right to make changes in equipment built and or sold by them at any time without incurring any obligation to make the same or similar changes on equipment previously built and or sold by them B 2 Bovie Medical Corporation e uhr I 55 5 0 MP CMM MP Ene MC 55 128 001 REV 6 2013 10 18 ud BOVIE MEDICAL CORPORATION 5115 Ulmerton Road Clearwater Florida 33760 U S Phone 1 800 537 2790 Fax 1 800 323 1640 International Phone 1 727 384 2323 www boviemed com C Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands go em MM
40. ically powers up to the Cut and Coag modes and their last selected power settings solated RF output This minimizes the potential of alternate site burns Standard connectors These connectors accept the latest monopolar and bipolar instruments 1 2 Bovie Medical Corporation Self diagnostics These diagnostics continually monitor the unit to ensure proper performance COMPONENTS AND ACCESSORIES To avoid incompatibility and unsafe operation we recommend using the following Bovie brand accessories supplied with your generator e Aaron 1250 Electrosurgical Generator Three electrodes ES20 ball ESO2 needle ESO1 blade e Hospital grade power cords 09 039 001 09 035 001 One reusable grounding cord A1252C User s Guide s Five disposable split grounding pads ESRE 1 One disposable pencil ESP1 S ESU Series I DVD ADDITIONAL ACCESSORIES To avoid incompatibility and unsafe operation we recommend using the following Bovie accessories with the A1250 BV 1253B Footswitch for Monopolar and Bipolar procedures 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 num
41. low fluids to enter the chassis Do not sterilize the generator PERIODIC INSPECTION Every six months visually inspect the Aaron 12507 for signs of wear or damage In particular look for any of the following problems Damage to the power cord Damage to the power cable receptacle Obvious damage to the unit Damage to any receptacle Accumulation of lint or debris in or around the unit FUSE REPLACEMENT Fuses for the unit reside directly below the Power Cable Receptacle on the rear of the unit To replace the fuses follow this procedure 1 Unplug the power cord from the wall outlet 2 Remove the power cord from the Power Cable Receptacle on the rear panel 3 To release the fuse drawer insert a small flathead screwdriver into the slot on the drawer below the power cord receptacle Then slide the drawer out 4 Remove the two fuses T3 15AL250V and replace them with new fuses with the same values 5 Insert the fuse holder into the Power Cable Receptacle NOTICE Figure 5 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 1250 6 1 The Aaron 1250 includes automatic self diagnostics If the diagnostics detect an error the system displays an error code sounds an audible tone and deactivates the unit output powe
42. lth NIOSH Control of Smoke from Laser Electric Surgical Procedures HAZARD CONTROLS Publication No 96 128 September 1996 CONTRAINDICATIONS There are no known contraindications NOTICES If required by local codes connect the generator to the hospital equalization connector with an equipotential cable Do not clean the generator with abrasive cleaning or disinfectant compounds solvents or other materials that could scratch the panels or damage the generator APPLICATION SPECIFICATION Operating Conditions RF energy is generated and passed through an interconnecting cable to an accessory where the energy is delivered to cut coagulate and ablate tissue Description The Aaron 1250U High Frequency Electrosurgical Generators models are intended to be used for all electrosurgical cut blend coagulation fulguration and bipolar procedures Medical Purpose Indication Removal and destruction of skin lesions Electrosurgical cutting blending coagulation fulguration and bipolar procedures of tissue to aid surgeon or physician in performing required procedures Site Condition Ambient luminance range 100 Ix to 1 500 Ix Viewing distance 20 cm to 200 cm Viewing angle normal to the display 30 Clean and protect from infection from start through completion of procedure Note the follow Conditions of visibility for use Ambient luminance range 100 Ix to 1 500 Ix Viewing distance 20 cm to 200 cm Viewin
43. n For all Monopolar modes any associated equipment and active electrodes must be rated to with stand the combination of output voltage vp p and crest factor as stated in Appendix A of this manual Associated equipment and accessories used must be rated to withstand the combination of the Vpeak rating and Crest Factor for the following RF modes Blend Pinpoint and Spray When using Cut mode associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 1250 Vpeak max Bovie Medical Corporation When using Blend mode associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 1850 Vpeak max When using Coagulation mode associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 3300 Vpeak max When using Fulguration mode associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 3900 Vpeak max When using Bipolar mode associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 1200 Vpeak max 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
44. n Checks Performance Checks User s Guide Aaron 1250 3 1 INITIAL INSPECTION When you first unpack your Aaron 1250 inspect it visually Look for any signs of damage Verify that the shipping package contains all items listed on the packing list If the unit or any accessories are damaged notify Bovie Medical Corporation s Customer Service immediately Do not use any damaged equipment INSTALLATION Place the Aaron 1250 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 position and that no accessories are connected to the unit 2 Connect a hospital grade power cable to the AC power cable receptacle on the back of the unit then to a properly grounded wall outlet 3 Connect a two pedal footswitch to the appropriate receptacle on the back of the unit Use only Bo
45. nd alarm tones return electrode and system alarms at a distance of one meter Alarm tones meet the requirements for IEC 6060122 Activation Tone Frequency Cut 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 Return Electrode Sensing Trip resistance 0 Q to 5 Q 3 O Continuous measurement Single Plate Once the system establishes the single plate electrode resistance an increase of 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 Q 10 Q Continuous measurement Split Plate Once the system establishes the split plate electrode resistance an increase of 40 in resistance will cause an alarm When the alarm condition exists the system deactivates output power The system presents audible and visible alarms when it senses no return electrode Low Frequency 50 60 Hz Leakage Current Enclosure source current ground open Normal polarity intact ground lt 10 pA Source current patient leads all outputs Normal polarity ground open 50 uA Reverse polarity ground open lt 50 pA Sink current at high line all inputs User s Guide Aaron 12507 A 3 High Frequency RF Leakage Current Bipolar RF leakage current lt 39 MA
46. nit will automatically sense the presence of a split or solid return electrode and if a split return electrode is used will constantly monitor the resistance at the contact between the electrode and the patient Connecting Accessories 1 Connect a monopolar active electrode to the unit If you are using Connect it to Standard 3 pin handswitching pencil Monopolar handswitching receptacle Footswitching pencil Monopolar footswitching receptacle NOTICE The Bovie NEM system recommends that you use a split return electrode 2 If using a footswitch activated device connect an appropriate Bovie Medical footswitch to the footswitch connect ing socket on the rear of the unit PREPARING FOR BIPOLAR SURGERY NOTICE Bipolar surgery does not require a return electrode 1 Select the Bipolar Mode by pressing the Bipolar Mode selector The Bipolar Mode indiactor will illuminate 2 Select Bipolar Foot Control by pressing the Foot Control selector 3 Connect a Bipolar cable to the Bipolar receptacle 4 Connect the appropriate Bovie Medical footswitch to the Footswitch receptacle on the rear of the unit 5 Connect a forceps instrument to the Bipolar cable User s Guide Aaron 12507 4 5 ACTIVATION SAFETY WARNINGS Ste oe a eee nee 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
47. of Bovie Medical Corporation Part number MC 55 128 001 Rev 6 CONVENTIONS USED IN THIS GUIDE Indicates a potentially hazardous situation which if not avoided could result in death or serious injury CAUTION Indicates a hazardous situation which if not avoided may result in minor or moderate injury NOTICE Indicates an operating tip a maintenance suggestion or a hazard that may result in product damage User s Guide Aaron 1250 iii TABLE OF CONTENTS Equipment Covered in this Manual sseeeeeeennnentenne iii For Information Gall ph e petet Htc Ar pres ii Conventions Used in this Guide sssseseeeenneeetetententens iii Introducing the AARON 12507 Electrosurgical Generator ss 1 1 indications Tor USO iacta leichte o hee te ea aep e peo bees 1 2 Operating Principles o tei e o e E ERR e ERU Rieti 1 2 Intended RE E EE aai deti ta he Rad pere De Oo HER EO REO EE 1 2 Key Features 3 eee imet e p I RE OI ERREUR UR D RRURUD ERREUR 1 2 Components and Accessories sse tentent tette 1 3 Additional ACCesSOr 6S 1 tpe ab retener erret te fem 1 3 Safety xit en deed p ep di ed OR RR E cu ipa 1 3 Controls Indicators and Receptacles eere eene nnns 2 1 Fon Panel cedet dd D ae EE teilt en ies 2 2 Symbols onthe Front Panel Anaie te pop Bose 2 3 Cut and Blend Controls cisien aa tentent 24 Coag
48. on Biplar Return Electrode Foot Control e 9 Power 9 Alarm o o Monopolar Bipolar Return Electrode Foot Control RGI Monopolar Bipolar _ 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 1250 SYMBOLS DESCRIPTION Cut Controls Cut Mode Blend Mode EE Coagulation Mode l A Fulguration Mode Bipolar Controls Bipolar Mode Indicators eo Split Return Electrode es Solid Return Electrode Regulatory Symbology e Mandatory Refer to instruction manual guide H Defibrillator Proof Type BF Equipment F RF Isolated patient connections are isolated from earth at high frequency An Warning Dangerous voltage Power Switch and Handpiece Connectors e Patient Return Electrode BRES Monopolar Output CL Bipolar Output User s Guide Aaron 1250 2 3 CUT AND BLEND CONTROLS Figure 2 2 Controls for the Cut and Blend Modes Cut and Blend Power Display watts Indicates the power set for Cut and Blend the Pure Cut or Blend Mode Activation Indicator Illuminates when you activate either Pure Cut or Blend Mode Cut Indicator Illuminates when Pure Cut Mode Cut Selector is selected When pressed selects C the Pure Cut Mode Blend Selector When pressed selects the Blend Mode Blen
49. on Specification 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 12507 SOCOM 1 1 INDICATIONS FOR USE The Aaron 1250 Electrosurgical Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue For the latest user information and technical bulletins visit www boviemed com OPERATING PRINCIPLES The Aaron 1250 Generator is a high frequency isolated generator featuring cutting up to 120 watts a blend mode 2 coagulation modes and 1 bipolar mode The generator offers a monopolar handpiece output monopolar foot con trolled output and bipolar foot controlled output The generator has a return electrode contact and quality moni toring system NEM to reduce the risk of patient burns at the return electrode site The pad sensing feature allows the user to use either a split or solid return electrode INTENDED USE The Aaron 1250 Electrosurgical Generator is intended for cutting coagulation ablation of tissue in general gynecologic orthopedic ENT and urological procedures performed in an operating suite and procedure room NOTICE The Aaron 1250 is not intended for Tubal Ligation KEY FEATURES The Aaron 1250 Elec
50. or damage the generator A Turn off the generator and unplug the power cord from the wall outlet B Thoroughly wipe all surfaces of the generator and power cord with a mild cleaning solution or disinfectant and a damp cloth Follow the procedures approved by your institution or use a validated infection control procedure Do not allow fluids to enter the chassis You cannot sterilize the generator Step 3 Ship the Generator A Attach a tag to the generator that includes the Returned Goods Authorization Number and the information hospital phone number etc listed in Step 1 Obtain a Returned Goods Authorization Number B Be sure the generator is completely dry before you pack it for shipment Although the preference is to have the Generator repackaged using its original packaging Bovie understands that this may not always be possible If necessary contact Customer Service for the proper packaging to ship the unit Please be sure to include a reference of the Bovie Return Goods Authorization Number on the outside of the box container C Ship the generator prepaid to the address given to you by the Bovie Medical Corporation Service Center 7 2 Bovie Medical Corporation ADDER n TECHNICAL SPECIFICATIONS All specifications are nominal and subject to change without notice A specification referred to as typical is within 20 of a stated value at room temperature 25 C 77 F and a nominal input power voltage Us
51. ould be selected that have a rated accessory voltage equal to or greater than 3300 Vpeak max When using Fulguration mode associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 3900 Vpeak max When using Bipolar mode associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 1200 Vpeak max 4 6 Bovie Medical Corporation CAUTIONS The use of high frequency current can interfere with the function of other electromagnetic equipment When high frequency surgical equipment and physiological monitoring equipment are used simultaneously on the same patient place any monitoring electrodes as far as possible from the surgical electrodes Do not use needles as monitoring electrodes during electrosurgical procedures Inadvertent electrosurgical burns may result To avoid the possibility of 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 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 Stu
52. ous oxide N2O and oxygen should be avoided if a surgical procedure is carried out in the region of the thorax or the head unless these agents are sucked away Non flammable agents should be used for cleaning and disinfection wherever possible Flammable agents used for cleaning or disinfecting or as solvents of adhesives should be allowed to evaporate before the application if HF surgery There is a risk of pooling flammable solutions under the patient or in body depressions such as the umbilicus and in body cavities such as the vagina Any fluids pooled in these areas should be mopped up before HF surgical equipment is used Attention should be called to the danger of ignition of endogenous gases Some materials for example cotton wool and gauze when saturated with oxygen may be ignited by sparks produced in Normal Use of the HF surgical equipment The generator is equipped with a return electrode sensing and contact quality monitoring system NEM which monitors the quality of the patient return electrode connection When a correctly functioning single plate return electrode is connected to the generator the NEM verifies the con nections between the generator and the single return electrode It DOES NOT verify that a single return electrode is in contact with the patient When using a split return electrode the NEM con firms the total resistance is within the preset safety range Proper application and visual inspection of the pati
53. priate IEC 60601 1 2 and IEC 60601 2 2 specifications regarding electromagnetic compatibility Voltage Transients Emergency Generator Mains Transfer The Aaron 1250 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 1250 Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual Understand that only the Accessories supplied with or ordered from Bovie Medical Corporation 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 A1250 The A1250 and its accessories are not suitable for interconnec tion with other equipment Portable and mobile RF communications equipment can affect Medical Electrical Equipment The 1250 should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the A1250TM 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 A1250 The 1250 is intended for use in an electromagnetic environment in which radiat
54. r Most error codes result from faults in accessories attached to the unit The following table lists the error codes describes the errors and recommends actions to take to resolve the errors If the unit displays any other error code it requires service Error Code Description Recommended Action iiu Handswitch or monopolar 1 Turn off then turn on the generator Do not press buttons or activate wr footswitch cut pedal may be stuck accessory devices during the self test l isplay 2 If the error code reappears disconnect all accessories Turn off then turn on the generator again F1 on the f Coagulation Handswitch or monopolar 3 If the problem persists replace the handpiece or footswitch Fulguration footswitch coag pedal may and repeat the restart Bipolar be stuck 4 If the error code reappears record the number and call display Bovie customer service Cut and Coag buttons activated The unit does not allow simultaneous activation of the cut and coagula F2 simultaneously tion modes Release either the cut or coag button on the handpiece or pencil or footswitch the cut or coag pedal on the footswitch Footswitch Cut or Coag pedal F3 pressed while in Bipolar Foot The unit will not allow the footswitch to activate the unit if Bipolar Control and the unit is not in footcontrol is selected but the Bipolar Mode is not selected Bipolar Mode 1 Turn the unit off E4 Line voltage error 2
55. r institution or to local codes Provide at least 10 to 15 cm 4 to 6 in of space from the sides and top of the generator for cooling Normally the top sides and rear panel are warm when you use the generator continuously for extended periods of time 3 Plug the generator power cord into the AC Power Cable Receptacle on the rear panel 4 Plug the generator power cord into a grounded receptacle 5 Turn on the generator by pressing the power switch On Verify the following All visual indicators and displays on the front panel illuminate Activation tones sound to verify that the speaker is working properly 6 If the self test is successful a tone sounds Verify the following A Cut mode is selected a Coag or Bipolar mode is selected Each display shows a power setting The unit automatically powers up to the Cut and Coag modes and their last selected power settings If the Blend Fulguration or Biploar mode is selected the unit will default to that modes last set power 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 Cut and or Coag display in most cases the generator is disabled Note the error code and refer to Section 6 Troubleshooting Once the self test is successful connect the accessories and set the generator controls Refer to Preparing for Monopolar Surgery or Preparing for Bipolar Surgery later in
56. rticular bipolar accessories must be connected to the Bipolar Instrument output jack only Improper connection may result in inadvertent generator activation Some accessories have multiple buttons that can deliver different surgical effects Verify accessory features and proper mode settings prior to activation The output power selected should be as low as possible for the intended purpose Certain devices or ACCESSORIES may present an unacceptable RISK at low power settings User s Guide Aaron 12507 1 5 1 6 Unless a compatible MONITORING NE is used with a CONTACT QUALITY MONITOR loss of safe contact between the NE and the PATIENT will not result in an auditory alarm The generator is equipped with a return electrode sensing and contact quality monitoring system NEM which monitors the quality of the patient return electrode connection When a correctly functioning single plate return electrode is connected to the generator the NEM verifies the con nections between the generator and the single return electrode It DOES NOT verify that a single return electrode is in contact with the patient When using a split return electrode the NEM con firms the total resistance is within the preset safety range Proper application such as hydrating the patient s skin and visual inspection of the patient return electrode is required for safe operation CAUTIONS At no time should you touch the active electrode or bipolar forceps
57. s are recommended 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 n addition place patient return electrodes according to the manufacturer s instructions Potential for alternate site burns increases if the return electrode is compromised Bovie Medical recommends the use of split patient return electrodes and Bovie Medical generators with a contact quality monitoring system Do not wrap the accessory cords or patient return electrode cords around metal objects This may induce currents that could lead to shocks fires or injury to the patient or surgical team Minor neuromuscular stimulation is possible when arcs between the ACTIVE ELECTRODE and tissue occur The generator has been designed to minimize the possibility of neuromuscular stimulation Accessories must be connected to the proper receptacle type In particular bipolar accessories must be connected to the Bipolar Instrument output jack only Improper connection may result in inadvertent generator activation The use of flammable anesthetics or oxidizing gases such as nitr
58. the skin in prepared properly and the pad is attached properly However be aware that extended surgical times particularly at high power will cause a continued temperature rise at the skin and return pad interface due to RF current return to the generator To avoid incompatibility and unsafe operation use suitable cables accessories active and neutral electrodes including values for the highest allowed H F peak voltage Some accessories have multiple buttons that can deliver different surgical effects Verify accessory features and proper mode settings prior to activation Connected accessories need be rated for at least the maximum peak output voltage of the H F generator set at the intended output control setting in the intended operating mode Associated equipment and accessories used must be rated to withstand the combination of the Vpeak rating and Crest Factor for the following RF modes Blend Pinpoint and Spray 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 4 2 Bovie Medic
59. this section 4 4 Bovie Medical Corporation PREPARING FOR MONOPOLAR SURGERY Monopolar surgery requires a return electrode Applying the Return Electrode Bovie Medical recommends using return electrode contact quality monitoring system Bovie NEM patient return electrodes to maximize patient safety Using a patient return electrode without the Bovie NEM safety feature may result in a patient burn NOTICES The Bovie NEM system recommends that you use a split plate patient 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 application site and placement procedures When using metal plate return electrodes use a conductive gel specifically designed for electrosurgery Select a return electrode site with good blood flow While a properly applied electrode results in minimal tissue heating beneath the electrode a good blood flow helps carry heat away from the site Connect the cable to the Return Electrode receptacle on the front of the unit The u
60. trosurgical Generator includes the latest technology This unit offers unsurpassed perform ance flexibility reliability and convenience It includes the following features Two levels of coagulation Pinpoint Coagulation and Fulguration Pinpoint Coagulation provides precise control of bleeding in localized areas Fulguration provides greater control of bleeding in highly vascular tissue over broad surface areas Return electrode sensing and contact quality monitoring The Aaron 1250 incorporates a return electrode contact quality monitoring system Bovie NEM This system determines the type of patient return electrode single or split plate The system also continually monitors the contact quality between the patient and the split plate return electrode This feature is designed to eliminate patient burns at the return electrode site NOTICES The Bovie NEM system recommends that you use a split plate patient 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 gen erator without secure contact to the patient the alarm indicator will illuminate red Memory The unit automat
61. vie Medical footswitches Although other types of footswitches may fit they may not be compatible 4 Do not connect a patient return electrode at this time 5 Turn the unit on by switching the power switch to the On position Checking the Return Electrode Alarm 1 Adjust the power settings for each mode Cut Blend Coagulation Fulguration and Bipolar to one watt 2 Press the Cut pedal of the footswitch Verify that an alarm sounds for three seconds and the Patient Return Electrode Sensing Alarm Indicator light illuminates indicating that no return electrode is connected to the unit 3 Verify that adjusting the volume control on the back of the unit while the alarm is sounding does not change the alarm volume 3 2 Bovie Medical Corporation CONFIRMING MODES Confirm that you can select each mode and adjust the power up and down Checking Bipolar Mode with footswitch 1 Select Bipolar mode by pressing the Bipolar Mode selector 2 Select Bipolar footcontrol by pressing the Footcontrol selector 3 Verify that the Bipolar mode indicator illuminates and that the system generates the Coag tone when you press the Coag pedal Blue on the footswitch 4 While activating the Bipolar mode rotate the volume control over the full range to verify that the sound is audible throughout the range 5 Confirm that releasing the Coag pedal returns the unit to an idle state Checking Monopolar Mode with footswitch 1 Select monopolar

Aaron 1250 (A1250U) User Guide

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