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.
TABLE OF CONTENTS Equipment Covered in this Manual ................iii For Information Call ....................iii Conventions Used in this Guide..................iii Introducing the AARON 1250™ Electrosurgical Generator ..........1-1 Indications for Use ......................1-2 Operating Principles ......................1-2 Intended Use ........................1-2 Key Features ........................1-2 Components and Accessories ..................1-3 Additional Accessories.....................1-3...
Page 6
Electromagnetic Interference...................A-4 Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2) ......A-4 Voltage Transients (Emergency Generator Mains Transfer)........A-4 EMC Compliance ......................A-4 Output Characteristics.....................A-8 Maximum Output for Monopolar and Bipolar Modes ..........A-8 Output Power Curves ......................A-9 Warranty..........................B-1 User’s Guide • Aaron 1250 ™...
Page 7
Figure A – 5 Output power vs impedance for Blend mode ..........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..........A-12 Bovie Medical Corporation...
Application 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 1250 ™...
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™...
WARNINGS Hazardous Electrical Output - This equipment is for use only by trained, licensed physicians. Danger: Fire / Explosion Hazard - Do not use the Aaron 1250™ 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: •...
Page 11
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.
Page 12
• In addition, place patient return electrodes according to the manufacturer’s instructions. Potential for alternate site burns increases if the return electrode is compromised. Bovie Medical recommends the use of split patient return electrodes and Bovie Medical generators with a contact quality monitoring system.
Page 13
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. Bovie Medical Corporation...
Page 14
Patient population • Age: newborn to geriatric • Weight: >2.5 kg • Health: no restrictions • Nationality: no restrictions • Patient state: alert, relaxed maybe sedated, possible local anesthesia – Patient should not be User User’s Guide • Aaron 1250 ™...
Page 15
Other: no special experience needed o No maximum • Permissible impairments: - Mild reading vision impairment or corrected vision to 20/20 - impaired by 40 % resulting in 60 % of normal hearing at 500 Hz to 2 kHz Bovie Medical Corporation...
CONTROLS, INDICATORS, AND RECEPTACLES This section describes: ● The Front and Rear Panels ● Controls, Indicators, Receptacles, the Fuse Drawer, and Ports User’s Guide • Aaron 1250 ™...
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 Coag Controls Coagulation Mode Fulguration Mode Bipolar Controls Bipolar Mode...
Blend Blend Selector When pressed, selects the Blend Mode. Blend Indicator Cut and Blend Power Control Dial Illuminates when Increases or decreases the Cut or Blend Blend Mode power output in increments of 1 watt. is selected. Bovie Medical Corporation...
Bipolar Indicator Coag and Bipolar Power Control Dial When pressed, selects Illuminates when Increases or decreases the Coag or Bipolar the Bipolar Mode. Bipolar Mode power output in increments of 1 watt. is selected. User’s Guide • Aaron 1250 ™...
NOTICE: Solid pad indicator only detects that a pad is connected to the unit. The unit does not monitor pad placement on the patient. Bovie Medical Corporation...
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. Connect footswitching accessories. User’s Guide • Aaron 1250 ™...
REAR PANEL Figure 2 – 6 Layout of connectors and controls on the rear panel SYMBOLS ON THE REAR PANEL Refer to the following table for descriptions of symbols found on the rear panel of the Aaron 1250™. SYMBOLS DESCRIPTION...
GETTING STARTED This section includes the following information: ● Initial Inspection ● Installation ● Function Checks ● Confirming Modes ● Performance Checks User’s Guide • Aaron 1250 ™...
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.
After the unit has passed the preliminary functional test, it is ready for performance testing. A qualified biomedical engineer who is thoroughly familiar with electrosurgical devices should conduct this testing. The testing should include checking all modes of operation for proper function and power output. User’s Guide • Aaron 1250 ™...
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 ™...
INSPECTING THE GENERATOR AND ACCESSORIES Before each use of the Aaron 1250™, verify that the unit and all accessories are in good working order: • Inspect for damage to the Electrosurgical Generator and all its connections. • Verify that the appropriate accessories and adapters are present.
Page 30
• In addition, place patient return electrodes according to the manufacturer’s instructions. Potential for alternate site burns increases if the return electrode is compromised. Bovie Medical recommends the use of split patient return electrodes and Bovie Medical generators with a contact quality monitoring system.
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. Bovie Medical Corporation...
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.
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: •...
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 1250 ™...
Page 35
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.
Do not allow fluids to enter the chassis. Do not sterilize the generator. PERIODIC INSPECTION Every six months, visually inspect the Aaron 1250™ for signs of wear or damage. In particular, look for any of the following problems: • Damage to the power cord •...
TROUBLESHOOTING This section includes Error Code Descriptions and actions to take to resolve them. User’s Guide • Aaron 1250 ™...
Page 39
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 power. Most error codes result from faults in accessories attached to the unit. The following table lists the error codes, describes the errors, and recommends actions to take to resolve the errors.
REPAIR POLICY AND PROCEDURES Refer to this section for information on: ● ● Responsibility of the Manufacturer ● ● Returning the Generator for Service User’s Guide • Aaron 1250 ™...
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. Bovie Medical Corporation...
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 1250 ™...
-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 5 0kPa to 106kPa Bovie Medical Corporation...
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.
Page 46
Harmonic emissions Class A nected to the public low-voltage IEC 61000-3-2 power supply network that sup- plies buildings used in domestic Voltage fluctuations/flicker purposes. emissions Complies IEC 61000-3-3 User’s Guide • Aaron 1250 ™...
Page 47
Hz) magnetic field 3 A/m of a typical location in a typical 3 A/m IEC 61000-4-8 commercial or hospital environment. NOTE U t is the a.c. mains voltage prior to application of the test level. Bovie Medical Corporation...
Page 48
If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the A1250™. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V ] V/m. User’s Guide • Aaron 1250 ™...
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) Figure A – 2 Output voltage (Vpeak) versus power setting (Bipolar) User’s Guide • Aaron 1250 ™...
Figure A – 5 Output power vs impedance for Blend mode Figure A – 6 Output power versus impedance for Coagulation modes User’s Guide • Aaron 1250 ™ A-11...
Figure A – 7 Output power versus impedance for Fulguration mode Figure A – 8 Output power vs impedance for Bipolar mode A-12 Bovie Medical Corporation...
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.
Page 55
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’s products.
Page 56
MC-55-128-001 REV. 8 2016-01-19 BOVIE MEDICAL CORPORATION • 511 5 Ulmerton Road Clearwater, Florida 33760 USA U.S. Phone 1-800-537-2790 • Fax 1-800-323-1640 International Phone + 1-727-384-2323 • www.boviemed.com 0413 Emerge Europe Molenstraat 1 5 2 51 3 BH, The Hague...