TOR A R E N E G L A OR | PRO 300 ELECTROSURGIC ELECTROSURGICAL GENERATOR USER’S GUIDE
USER’S GUIDE User ’s Guide • Aaron® OR│PRO 300 i
ii Bovie Medical Corporation
This manual and the equipment it describes are for use only by qualified medical professionals trained in the particular technique and surgical procedure to be performed. It is intended as a guide for using the Aaron® OR│PRO 300 only. Additional technical information is available in the Aaron® OR│PRO 300 Service Guide. For the latest information and technical bulletins, visit www.boviemed.com. Equipment Covered in this Manual Aaron® OR│PRO 300 Reference No.
TABLE OF CONTENTS Equipment Covered in this Manual............................................................................iii For Information Contact .............................................................................................iii Conventions Used in this Guide ........................................................................................iii Introducing the Aaron® OR│PRO 300................................................................................
Memory Feature (Last Selected RF Preset) ...........................................................4-7 Setting and Selecting Bipolar Preferences Presets for Bipolar Modes...........................4-8 Bipolar Set-Up Preferences.....................................................................................4-9 BipolarSet-Up Preferences Function Overview.......................................................4-9 Bipolar Set-Up Preferences Options ..........................................................
LIST OF FIGURES Figure 2 – 1 Layout of controls, indicators, and receptacles on the front panel..................2-2 Figure 2 – 2 Layout of connectors and controls on the rear panel....................................2-10 Figure 5 – 1 Fuse holder......................................................................................................5-2 Figure A – 1 Power setting versus maximum voltage (Vpeak) CUT ...................................
INTRODUCING THE AARON® OR│PRO 300 This section includes the following information: ● Indications for Use ● Operating Principle ● Intended Use ● Safety ● Contraindications ● Application Specification ● Key Features ● Components and Accessories ● Additional Accessories CAUTIONS: Read all warnings, cautions, and instructions provided with this generator before using. Read the instructions, warnings, and cautions provided with electrosurgical accessories before using.
INDICATIONS FOR USE The Aaron® OR│PRO 300 Electrosurgical Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue. For the latest user information and technical bulletins, visit www.boviemed.com. OPERATING PRINCIPLE RF energy is generated and passed through an interconnecting cable to an accessory where the energy is delivered to cut, coagulate and ablate tissue.
Electric Shock Hazard - Connect the generator power cord to a properly grounded receptacle. Do not use power plug adapters. Electric Shock Hazard - Always turn off and unplug the generator before cleaning. Active cord removal during activation could result in a shock to the operator at the generator connector plug interface should activation occur by footswitch. Fire Hazard - Do not use extension cords. Patient Safety - Use the generator only if the self-test has been completed as described.
When using Blend mode, associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 1870 Vpeak max. When using Coagulation mode, associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 4000 Vpeak max. When using Bipolar mode, associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 600 Vpeak max.
The output power selected should be as low as possible for the intended purpose. Certain devices or ACCESSORIES may present an unacceptable RISK at low power settings. Failure of the HF SURGICAL EQUIPMENT could result in an unintended increase of output power. Unless a compatible MONITORING NE is used with a CONTACT QUALITY MONITOR, loss of safe contact between the NE and the PATIENT will not result in an auditory alarm.
Remove any loose fitting jewelry from the patient before activation. Examine all accessories and connections to the electrosurgical generator before use. Ensure that the accessories function as intended. Improper connection may result in arcs, sparks, accessory malfunction, or unintended surgical effects. When not using active accessories, place them in a holster or in a clean, dry, non-conductive, and highly visible area not in contact with the patient.
- Understands electrosurgery and electrosurgical techniques; - Read and understands supplied User’s Guide (Accompanying Document) - Understands hygiene - Maximum: - There is no maximum • Language Understanding: - Languages as specified in the marketing distribution plan • Experience: - Minimum: - Some training on techniques or training under surveillance/supervision - No special experience needed - Maximum: - There is no maximum - Permissible Impairments: - Mild reading / vision impairment or vision correct
• Micro Bipolar Mode The Micro Bipolar Mode provides precise Bipolar coagulation effects. • Standard Bipolar Mode The Standard Bipolar Mode provides power for conventional Bipolar output. • Bovie® Bipolar Mode The Bovie® Bipolar Mode is a special pulsing coagulation mode that delivers quick, precise and powerful coagulation to achieve optimal surgical fusion effects to most tissue types.
• Self diagnostics These diagnostics continually monitor the unit to ensure proper performance.
1-10 Bovie Medical Corporation
CONTROLS, INDICATORS, AND RECEPTACLES This section describes: ● The Front and Rear Panels ● Controls, Indicators, Receptacles, and Ports User ’s Guide • Aaron® OR│PRO 300 2-1
FRONT PANEL Figure 2 – 1 Layout of controls, indicators, and receptacles on the front panel Symbols on the Front Panel Refer to the following table for descriptions of symbols found on the front panel of the Aaron® OR│PRO 300.
Symbols on the Front Panel Continued Refer to the following table for descriptions of symbols found on the front panel of the Aaron® OR│PRO 300. SYMBOLS DESCRIPTION Selection Select / Toggle / Adjust Settings Select Set Indicators Split Return Electrode Solid Return Electrode Regulatory Symbology Mandatory: Refer to instruction manual / guide Defibrillator Proof Type CF Equipment RF Isolated – patient connections are isolated from earth at high frequency.
PRESET CONTROLS Preset / SetUp Preferences Display Preset indicates the current selection of one of the 10 RF presets (0-9). Indicates the current selection of one of the 6 Bipolar Setup Preferences presets (a-f) in Bipolar “setup”. Also indicates a dash “–” when a Preset is not selected. Select Button Toggles through the 10 RF presets or 6 Bipolar setup preferences. Set Button Sets the desired preset into one of the 10 user-defined presets or the 6 Bipolar setup preferences.
MONOPOLAR POWER OUTPUT MODES Blend Level Control Buttons Increases or decreases the blend Level (1-4) only applicable to the Blend mode. Monopolar Cut Power Display (watts) Indicates the power set for the selected Cut / Blend mode. Cut and Blend Power Control Buttons Displays error/fault code in the Increases or decreases the selected Cut event of an error or fault. mode output power setting. Cut I Mode Indicator Illuminates green when the Cut I mode is selected.
COAG CONTROLS Coag Power Display (watts) Indicates the power set for the selected Coag mode. Displays error/fault codes in the event of an error or fault. Coag Activation Indicator Illuminates when Coag mode is activated. (illuminates blue) Coag Power Control Buttons Increases or decreases the selected Coag mode output power setting. Pinpoint Mode Indicator Illuminates green when the Pinpoint mode is selected.
BIPOLAR MODE AND AUTO BIPOLAR CONTROLS Bipolar Power Display (watts) Indicates the power set for the Bipolar modes. Displays error/fault codes in the event of an error or fault. Bipolar Activation Indicator Illuminates when the Bipolar mode is activated. (illuminates blue) Macro Mode Indicator Illuminates green when the Macro Bipolar mode is selected. Micro Mode Indicator Illuminates green when the Micro Bipolar mode is selected.
INDICATORS Power Indicator Illuminates green when the main power is on. Split Return Electrode Indicator Illuminates green when the system detects a split plate is properly placed on the patient. Solid Return Electrode Indicator Illuminates green when the system detects a single plate. Alarm Indicator Illuminates red when the system detects a return electrode alarm condition. Solid pad indicator only detects that a pad is connected to the unit. The unit does not monitor pad placement on the patient.
POWER SWITCH AND RECEPTACLES Return Electrode Receptacle Accepts a standard return electrode plug. Power On/Off Switch Turns the unit on or off. Monopolar 2 Handswitching Receptacle Accepts standard 3-pin handpieces. Connect handswitching accessories. Monopolar 1 Handswitching/ Footswitching Receptacle Accepts standard 3-pin handpieces or accepts footswitching adapter (A1210A) or cable (A1210D or A1210R). Connect handswitching accessories.
REAR PANEL Figure 2 – 2 Layout of connectors and controls on the rear panel Symbols on the Rear Panel Refer to the following table for descriptions of symbols found on the rear panel of the Aaron® OR│PRO 300. SYMBOLS DESCRIPTION Equipotential Ground Stud Non-ionizing Radiation Volume Control Danger - Explosion Risk If Used With Flammable Anesthetics.
GETTING STARTED This section includes the following information: ● Initial Inspection ● Installation ● Preliminary Function Checks ● Preliminary Performance Checks User ’s Guide • Aaron® OR│PRO 300 3-1
INITIAL INSPECTION When you first unpack your Aaron® OR│PRO 300, 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® OR│PRO 300 on any flat surface with a tilt angle not more than 10˚. The unit relies on natural convection cooling.
3. Verify that adjusting the volume control on the back of the unit while the alarm is sounding does not change the alarm volume. PRELIMINARY PERFORMANCE CHECKS After the unit has passed the preliminary functional test, it is ready for performance testing. A qualified biomedical engineer who is thoroughly familiar with electrosurgical devices should conduct this testing. The testing should include checking all modes of operation for proper function and power output.
3-4 Bovie Medical Corporation
USING THE AARON® OR│PRO 300 This section contains the following procedures: Inspecting the Generator and Accessories Setup Safety Confirming Modes Setting Up for Surgery Preparing for Monopolar Surgery Preparing for Bipolar Surgery Setting and Selecting Memory Presets Setting and Selecting Bipolar Preferences Presets for Bipolar Modes Activating the Unit Auto Bipolar Activation Activation Safety CAUTIONS: Read all warnings, cautions, and instructions provided with
INSPECTING THE GENERATOR AND ACCESSORIES Before each use of the Aaron® OR│PRO 300, verify that the unit and all accessories are in good working order: • Inspect for damage to the Electrosurgical Generator and all its connections. • Verify that the appropriate procedure accessories and adapters are present. • Inspect all cords and connectors for signs of wear, damage, and abrasion. • Verify that no errors occur when you turn on the unit.
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.
3. While activating the Bipolar mode, rotate the volume control over the full range to verify that the sound is audible throughout the range. 4. Confirm that releasing the pedal returns the unit to an idle state. Checking Monopolar Mode (with monopolar footswitch) 1. Plug in the Monopolar footswitch (BV1253B). 2. Connect a solid return electrode to the return electrode receptacle. Verify that the green solid return electrode indicator illuminates. 3.
6. If the self-test is successful, a tone sounds. Verify the following: • A Cut mode is selected; a Coag mode is selected; a Bipolar mode is selected. • Each display shows a power setting. The unit automatically powers up to the last successfully activated mode and power setting. • The Patient Return Electrode Alert Indicator illuminates red. If the self-test is not successful, an alert tone sounds. An error code will be displayed, and in most cases, the generator is disabled.
Connecting Accessories 1. Connect a 3-pin monopolar device into one of the monopolar receptacles on the front of the unit. If you are using… Connect it to… Standard 3-pin handswitching pencil Monopolar handswitching receptacle 1 or 2 Footswitching pencil Monopolar footswitching receptacle 1 (via A1210A) If footswitching control capabilities are preferred, connect the Bovie® monopolar footswitch (BV-1253) to the appropriate monopolar footswitch connecting socket on the rear of the unit.
Macro, Micro and Standard Bipolar Modes Bovie® Bipolar Mode From 0>= to <150ma +/- 10% No LEDs illuminated From 0>= to <150ma +/- 10% No LEDs illuminated From 150 to >300ma +/- 10% 1 LEDs illuminated From 150 to 500ma +/- 10% 1 LEDs illuminated From 300 to 400ma +/- 10% 2 LEDs illuminated From 500 to 850ma +/- 7% 2 LEDs illuminated From 400 to 550ma +/- 7% 3 LEDs illuminated From 850 to 1200ma +/- 5% 3 LEDs illuminated From 550 to 700ma +/- 7% 4 LEDs illuminated From 1200 to 1600ma +/- 5
• Presets only store one Cut mode (Cut I or Cut II, or Blend) and power setting, one Blend level (if applicable), one Coag mode (Pinpoint, Spray or Gentle) and power setting, and one Bipolar (Macro, Micro, Standard or BBp) power setting. When storing, only the information displayed in the display windows will be saved to the unit’s memory. Setting Your Presets Select the desired preset (0-9) by pressing the select button.
Auto Bipolar (Macro, Micro, Standard) Start impedance 20-1000 ohms Stop Impedance, user configurable, 1500, 1800, 2000 ohms. Default 1500Ω Delay times, user configurable, 0, 500ms, 1000ms, 1500ms, 2000ms. Default = 1000ms. Note: Unit always powers up with this default setting Pulsing, user configurable on and off times. Times 0 – 1000ms on/off in 50ms increments. Default Pulsing On Time = 250ms Note: Unit always powers up with this default setting.
desired preset. At this time, all buttons are disabled. While in the Bipolar set-Up mode, the user shall be able to toggle the Ammeter audio on or off for the Bipolar ammeter. The unit default is ON. While in the Bipolar set-up mode the user shall be able to adjust the auto bipolar stop impedance. The unit default is 1500Ω. While in the Bipolar set-up mode the user shall be able to adjust the auto bipolar delay time.
1. Depress the Bipolar Set-Up button. 2. The Set-Up LED will be illuminated.. 3. Press the Coag down wattage power arrow twice. The 3 sets of seven-segment displays will update to show one of the following: STP1.50 OH STP1.80 OH STP 2.00 OH 5. To select the desired Auto Bipolar stop impedance press the Coag Up or Down wattage power arrows. The user can select 1500Ω, 1800Ω or 2000Ω. Note 1.50kΩ = 1500Ω, 1.80kΩ = 1800Ω, 2.00kΩ = 2000Ω. Default is 1500Ω. 6.
ON --- SEC 5. To select the desired Bovie Bipolar Pulse On time, press the Coag Up or Down wattage power arrows. The user can select values in 50 Millisecond increments between 0 – 1000ms. The default is 250 Milliseconds = .25 SEC. 6. The user Preset LED will be flashing if Pulse Time adjusted away from default. 7. The user can now select another parameter to edit but depressing the Cut up or down power arrows or can exit the Set-Up mode by depressing the Set-Up button once.
5. Activate the generator by pressing the appropriate button on the handpiece or pedal on the footswitch. NOTICE: Monopolar and bipolar footswitching operations are controlled by independent foot controls. 6. After use, turn off the generator by pressing the power switch OFF (O). 7. Unplug the generator power cord from the grounded receptacle. AUTO BIPOLAR ACTIVATION The Auto Bipolar feature must be set up using the Bipolar Set-Up Preferences.
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 Aaron® OR│PRO 300 RF to function correctly at the normal operating settings may indicate faulty application of the neutral electrode or poor contact in its connections. In this case, the application of the neutral electrode and its connections should be checked before selecting a higher output power.
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.
4-16 Bovie Medical Corporation
MAINTAINING THE AARON® OR│PRO 300 This section covers the following topics: ● Cleaning ● Periodic Inspection ● Fuse Replacement User ’s Guide • Aaron® OR│PRO 300 5-1
Bovie Medical Corporation recommends that you complete periodic inspection and performance testing. Perform inspections and performance testing every six months. A qualified biomedical technician should conduct this testing to ensure that the unit is operating effectively and safely. CLEANING After each use, clean the unit. WARNING: Electric Shock Hazard - Always turn off and unplug the generator before cleaning.
TROUBLESHOOTING This section includes Error Code Descriptions and actions to take to resolve them.
The Aaron® OR│PRO 300 includes automatic self-diagnostics. If the diagnostics detect an error, the system displays an error code, sounds an audible tone, and deactivates the unit output power. Most error codes result from faults in accessories attached to the unit. The following table lists the error codes, describes the errors, and recommends actions to take to resolve the errors. All error codes are displayed in the Bipolar display. If the unit displays any other error code, it requires service.
SYSTEM FATAL ERROR MESSAGES Error messages (E) indicate internal problems with the unit. Error Code Description E1 Output Current out of Specification, Digital Check E4 DC Voltage Error E5 Temperature Sense Error 1 E6 Temperature Sense Error 2 E7 NEM / Autobipolar Error E8 NEM Calibration Error E9 A/D Error E10 Watch Dog Error E11 Relay Board Cable Sense Error E12 Dosage Error User ’s Guide • Aaron® OR│PRO 300 Recommended Action 1.
6-4 Bovie Medical Corporation
REPAIR POLICY AND PROCEDURES Refer to this section for information on: ● Responsibility of the Manufacturer ● Returning the Generator for Service User ’s Guide • Aaron® OR│PRO 300 7-1
RESPONSIBILITY OF THE MANUFACTURER Bovie® is responsible for the safety, reliability, and performance of the generator only under the following circumstances: • • • • The user has followed the Installation and Setup Procedures in this User’s Guide. Persons authorized by Bovie Medical Corporation performed assembly operation, readjustments, modifications, or repairs. The electrical installation of the relevant room complies with local codes and regulatory requirements, such as IEC and BSI.
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.
PERFORMANCE CHARACTERISTICS Input Power Input Voltage 100-240V~ ± 10% Mains line frequency range (nominal): 50 – 60 Hz Power consumption: 560 VA Fuses (two): 6.3 A (slow blow) Duty Cycle Under maximum power settings and rated load conditions (Cut I, 300 watt @ 300 ohm load), the generator is suitable for activation times of 10 seconds ON followed by 30 seconds OFF for 30 minutes. The internal temperature of the unit is continuously monitored.
Audio Volume The audio levels stated below are for activation tones (cut, coag, and bipolar) and alert tones (return electrode and system alerts) at a distance of one meter. Alert tones meet the requirements for IEC 60601-2-2.
High Frequency (RF) Leakage Current Bipolar Micro, Macro leakage current < 63 mA rms Bipolar Standard leakage current < 50 mA rms Bovie Bipolar leakage current < 105 mA rms Monopolar RF leakage current < 150 mA rms Operating Conditions RF energy is generated and passed through an interconnecting cable to an accessory where the energy is delivered to cut, coagulate and ablate tissue.
OUTPUT CHARACTERISTICS Maximum Output for Monopolar and Bipolar Modes Power readouts agree with actual power into rated load to within 20% or 5 watts, whichever is greater. Crest Factor* Mode Max Power Rated Load Output Frequency Repetition Rate Duty Cycle Vpeak max Cut I 300 W 300 Ω 490 kHz ± 4.9 kHz N/A N/A 1000V 1.7 ± 20% Cut II 300 W 300 Ω 490 kHz ± 4.9 kHz N/A N/A 750V 1.7 ± 20% Blend (1) 200 W 300 Ω 490 kHz ± 4.9 kHz 30 kHz ± 5 kHz 75% duty cycle 1320V 1.
Portable and mobile RF communications equipment can affect Medical Electrical Equipment. The Aaron® OR│PRO 300 should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the OR│PRO 300 should be observed to verify normal operation in the configuration in which it will be used.
Guidance and manufacturer’s declaration – electromagnetic immunity The OR│PRO 300 is intended for use in the electromagnetic environment listed below. The customer or the user of the OR│PRO 300 should assure that is is used in such an environment. IEC 60601 test level Immunity test Compliance level Electromagnetic environment - guidance Electrostatic discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV air ±6 kV contact ±8 kV air Floors should be wood, concrete or ceramic tile.
Guidance and manufacturer’s declaration – electromagnetic immunity continued... Immunity test Conducted RF IEC 61000-4-6 IEC 60601 test level Compliance level 3 Vrms 150 kHz to 80 3 Vrms MHz Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the OR│PRO 300, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
OUTPUT POWER CURVES Figures A–1 through A–4 illustrate power setting versus maximum voltage (Vpeak). Figure A–5 illustrates output power versus power setting for all modes. Figures A–6 through A–15 illustrate specific output power delivered to a range of load resistances for each mode.
Figure A – 3 Power setting versus maximum voltage (Vpeak) BIPOLAR Macro, Micro and Standard Figure A – 4 Power setting versus maximum voltage (Vpeak) Bovie® BIPOLAR A-10 Bovie Medical Corporation
Figure A – 5 Output power all modes versus power setting at rated loads User ’s Guide • Aaron® OR│PRO 300 A-11
Figure A – 6 Output power versus impedance for Cut I mode Figure A – 7 Output power versus impedance for Cut II mode A-12 Bovie Medical Corporation
Figure A – 8 Output power versus impedance for Blend (1, 2, 3, 4) mode Figure A – 9 Output power vs impedance for Pinpoint mode User ’s Guide • Aaron® OR│PRO 300 A-13
Figure A – 10 Output power vs impedance for Spray mode Figure A – 11 Output power vs impedance for Gentle Coagulation mode A-14 Bovie Medical Corporation
Figure A – 12 Output power vs impedance for Macro Bipolar mode Figure A– 13 Output power vs impedance for Micro Bipolar mode User ’s Guide • Aaron® OR│PRO 300 A-15
Figure A – 14 Output power vs impedance for Standard Bipolar mode Figure A – 15 Output power vs impedance for Bovie® Bipolar (Continuous, Non Pulsing) mode A-16 Bovie Medical Corporation
WARRANTY Bovie Medical Corporation, warrants each product manufactured by it to be free from defects in material and workmanship under normal use and service for the period(s) set forth below.
This warranty is in lieu of all other warranties, express or implied, including without limitation, the warranties of merchantability and fitness for a particular purpose, and of all other obligations or liabilities on the part of Bovie Medical Corporation. Bovie Medical Corporation neither assumes nor authorizes any other person to assume for it any other liability in connection with the sale or use of any of Bovie Medical Corporation’s products.
MC-55-230-001 Rev. 1 2014-12-30 • Cart, Smoke Shark® and Footswitches Sold Separately Bovie Medical Corporation 5115 Ulmerton Road Clearwater, FL 33760 USA U.S. Phone 1-800-537-2790 • Fax 1-800-323-1640 Int’l. Phone +1-727-384-2323 • Fax +1-727-347-9144 www.boviemed.com • sales@boviemed.
