BANTAM PRO Users Guide Jan 2019

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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 Bantam Pro Electrosurgical Generator only. Additional technical information is available in the Bantam Pro Service Guide.

Equipment Covered in this Manual Bovie Bantam Pro Electrosurgical Generator: Model No.: A952

For Information Call Bovie Medical • Clearwater, FL BovieMedical.com • [email protected] U.S. Phone +1 800-251-3000 • Int’l. Phone +1 615-964-5532 ©2018 Bovie Medical Corporation. All rights reserved. Contents of this publication may not be reproduced without the written permission of Bovie Medical Corporation. Bovie Part Number: MC-55-238-001_2-EN Manufactured by Bovie Medical Corporation.

Emergo Europe Prinsessegracht 20 2514 AP, The Hague The Netherlands

CONVENTIONS USED IN THIS GUIDE WARNING: 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.

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TABLE OF CONTENTS

Equipment Covered in this Manual...iii For Information Call...iii Conventions Used in this Guide...iii

Introducing the Bantam Pro Electrosurgical Generator...1-1 Key Features...1-2 Components and Accessories...1-3 Safety ...1-3 Contraindications ...1-7 Application Specifications...1-7 Controls, Indicators, and Receptacles...2-1 Front Panel...2-2 Symbols on the Front Panel ...2-3 Front Panel Controls...2-4 Indicators and Receptacles ...2-5 Rear and Side Panels ...2-6 Symbols on the Rear and Side Panels...2-6 Getting Started ...3-1 Initial Inspection...3-2 Installing the Unit ...3-2 Using the Bantam Pro ...4-1 Inspecting the Generator and Accessories ...4-2 Setup Safety ...4-2 Setting Up ...4-3 Preparing for Monopolar Surgery ...4-4 Applying the Patient Return Electrode...4-4 Preparing for Bipolar Surgery ...4-5 Activation Safety ...4-6 Activating the Unit ...4-7 Monopolar Activation...4-7 Bipolar Activation...4-7 Maintaining the Bantam Pro ...5-1 Cleaning ...5-2 Periodic Inspection ...5-2 Fuse Replacement ...5-2 Service and Repair...5-3 Troubleshooting...6-1 System Fault Code Messages...6-2 System Fatal Error Messages ...6-2 Repair Policy and Procedures...7-1 Responsibility of the Manufacturer ...7-2 Returning the Generator for Service ...7-2 Step 1 – Obtain a Returned Goods Authorization Number...7-2 Step 2 – Clean the Generator...7-2 Step 3 – Ship the Generator...7-2

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Technical Specifications...A-1 Performance Characteristics...A-2 Input Power ...A-2 Duty Cycle ...A-2 Dimensions and Weight...A-2 Operating Parameters...A-2 Transport ...A-2 Storage ...A-2 Audio Volume ...A-3 Return Electrode Sensing...A-3 Low Frequency (50–60 Hz) Leakage Current ...A-3 High Frequency (RF) Leakage Current...A-4 Operating Conditions ...A-4 Standards and IEC Classifications ...A-4 Class I Equipment (IEC 60601-1) ...A-4 Type BF Equipment (IEC 60601-1) ...A-4 Ingress Protection Rating (EN 60529) ...A-4 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-5 Output Characteristics ...A-7 Maximum Output for Bipolar and Monopolar Modes...A-7 Output Power Curves ...A-8 Warranty ...B-1

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LIST OF FIGURES

Figure 2 – 1 Layout of controls, indicators, and receptacles on the front panel ...2-2 Figure 2 – 2 Controls and indicators for the cut, blend, coag, fulguration, bipolar, and micro bipolar modes .2-4 Figure 2 – 3 Indicators and receptacles ...2-5 Figure 2 – 4 Layout of controls and indicators on the rear and side panel ...2-6 Figure 4 – 1 Setup procedures...4-8 Figure A – 1 Output voltage (Vpeak) versus power setting (Monopolar) ...A-9 Figure A – 2 Output voltage (Vpeak) versus power setting (Fulgaration) ...A-9 Figure A – 3 Output voltage (Vpeak) versus power setting (Bipolar) ...A-9 Figure A – 4 Output voltage (Vpeak) versus power setting (Micro Bipolar) ...A-9 Figure A – 5 Output power versus power setting for all modes ...A-10 Figure A – 6 Output power vs impedance for Cut mode...A-10 Figure A – 7 Output power vs impedance for Blend mode...A-11 Figure A – 8 Output power versus impedance for Coagulation mode ...A-11 Figure A – 9 Output power versus impedance for Fulguration mode ...A-12 Figure A – 10 Output power vs impedance for Bipolar mode...A-12 Figure A – 11 Output power vs impedance for Micro Bipolar mode ...A-13

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INTRODUCING THE BANTAM PRO ELECTROSURGICAL GENERATOR This section includes the following information: l Key Features l Components and Accessories l Safety l Contraindications l Application Specifications 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.

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KEY FEATURES The Bantam Pro Electrosurgical Generator includes the latest technology. This unit offers unsurpassed performance, flexibility, reliability, and convenience. It includes the following features: • Cut Mode The Cut mode gives the surgeon flexibility to cut all types of tissue without losing performance. It generates constant output power over a wide range of impedances. Refer to Appendix A, Technical Specifications section of this guide. • Blend Mode The Blend mode is a combination of cutting and hemostasis. The Blend mode improves the rate of targeted tissue desiccation without increasing the power delivered by the generator. • Coagulation Mode Coagulation provides precise control of bleeding in localized areas. • Fulguration Mode Fulguration produces a sparking at the skin surface for more shallow tissue destruction. In the Fulguration mode, the use of a patient return electrode is optional. • Micro Bipolar Mode The Micro Bipolar Mode provides power for conventional Bipolar output. • Bipolar Mode The Standard Bipolar Mode provides precise Bipolar coagulation effects. • Return electrode sensing and contact quality monitoring The Bantam Pro incorporates a return electrode contact quality monitoring system (Bovie NEM™). This system detects the type of return electrode: solid or split. The system also continually monitors the contact quality between the patient and the split return electrode. This feature is designed to minimize patient burns at the return electrode site. NOTICES: The Bovie NEM™ system recommends that you use a split return electrode. Before activation, pad placement and visual verification of the split return electrode (split pad) indicator on the front panel is recommended. After connecting the split pad to the generator and placing the split pad securely to the patient, give the unit 3 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.

• Four Front Panel Accessory Connections These connectors accept a monopolar instrument, a bipolar instrument, a return patient grounding pad, and a footswitch. Refer to Section 2, Controls, Indicators, and Receptacles to learn more. • Memory The unit automatically powers up to the last activated mode and power settings. • Isolated RF output This minimizes the potential of alternate site burns • Self diagnostics These diagnostics continually monitor the unit to ensure proper performance.

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COMPONENTS AND ACCESSORIES To avoid incompatibility and unsafe operation, we recommend using the following Bovie® or Aaron® brand accessories supplied with your generator (Applied Parts*): • Bantam Pro Electrosurgical Generator • *6 sterile and 12 non-sterile dermal tips • *Five disposable electrodes (3 blades, 1 ball, 1 needle) • *Two reusable grounding cord (9.8ft (3m)) • *Five disposable grounding pads • Two sterile A910ST handpiece drapes

• *A902 Handpiece (9.8ft (3m)) • Two non-sterile A910 handpiece drapes • Hospital-grade power cord (10ft (3.048m)) • Wall mount bracket • User’s Guide / Service Guide on CD

Additional Accessories To avoid incompatibility and unsafe operation, we recommend using the following Bovie® or Aaron® accessories with the A952. • A827V – Bipolar Forceps Cord (10.5ft (3.2m)) • A803 Footswitch (9.8ft (3m))

SAFETY The safe and effective use of electrosurgery depends to a large degree on factors solely under the control of the operator. There is no substitute for a properly trained and vigilant medical staff. It is important that they read, understand, and follow the operating instructions supplied with this electrosurgical equipment. Physicians have used electrosurgical equipment safely in numerous procedures. Before starting any surgical procedure, the surgeon should be familiar with the medical literature, complications, and hazards of using electrosurgery in that procedure. To promote the safe use of the Bantam Pro Electrosurgical Generator, this section presents the warnings and cautions that appear throughout this user’s guide. So that you can operate this equipment with maximum safety, it is important that you read, understand, and follow the instructions in these warnings and cautions. It is also important that you read, understand, and follow the instructions for use in this user’s guide. WARNINGS: Hazardous Electrical Output - This equipment is for use only by trained, licensed physicians. Danger: Fire / Explosion Hazard - Do not use the Bantam Pro 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 [N20] 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. 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 equipment is used. Attention should be called to the danger of ignition of endogenous gases.

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WARNINGS: 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. 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. Disconnect power cord from power source or unplug the power cord from the unit’s power inlet to isolate the internal circuits from the supply mains. No modification of this equipment is allowed. This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the ME EQUIPMENT or ME SYSTEM or shielding the location. 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 earth. Active cord removal during activation could result in a shock to the operator at the generator connector plug interface should activation occur by footswitch. 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 electrode only for the minimum time necessary in order to lessen the possibility of unintended burn injury. Pediatric applications and/or procedures performed on small anatomic structures may require reduced power settings. The higher the current flow, and the longer the current is applied, the greater the possibility of unintended thermal damage to tissue, especially during use on small structures. 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. For all monopolar modes, if the Generator is activated with the rated duty cycle of 10 seconds on / 30 seconds off, the surface skin temperature under the Bovie® patient return pads will not rise by more than 6°C if the skin and pad are prepared properly. However, be aware that activation times longer than the rated duty cycle of 10 seconds on / 30 seconds off, particularly at high power settings, the surface skin that is under the Bovie patient return pads may continue increasing in temperature by more than 6°C. 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 Bantam Pro 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. 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.

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WARNINGS: 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. For all Monopolar modes, except Cut mode, any associated equipment and active electrodes must be rated to withstand 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 all RF modes. When using Cut mode, associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 1600 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 2100 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 2900 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 6300 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 950 Vpeak max. When using Micro Bipolar mode, associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than 300 Vpeak max. Use electrosurgery with caution in the presence of internal or external devices such as pacemakers or pulse generators. Interference produced by the use of electrosurgical devices can cause devices such as pacemakers to enter an asynchronous mode or can block the pacemaker effect entirely. Consult the device manufacturer or hospital Cardiology Department for further information when use of electrosurgical appliances is planned for patients with cardiac pacemakers or other implantable devices. If the patient has an Implantable Cardioverter Defibrillator (ICD), contact the ICD manufacturer for instructions before performing an electrosurgical procedure. Electrosurgery may cause multiple activation of ICDs. 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 NE 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 simultaneously 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 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. • 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.

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WARNINGS: 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. Temporarily unused active electrodes should be stored in a location that is isolated from the patient. 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. 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. 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 connections 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 confirms 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. A return electrode is not required for the fulguration mode. The patient plate alarm is not used for this mode. Procedures may be performed without the use of a return electrode.

CAUTIONS: At no time should you touch the active electrode or bipolar forceps. A burn could result. Do not stack equipment on top of the generator or place the generator on top of electrical equipment. These configurations are unstable and/or do not allow adequate cooling. Provide as much distance as possible between the electrosurgical generator and other electronic equipment (such as 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. When using Monopolar mode, associated equipment and active accessories should be selected that have a voltage rating of 6.3 kVp or greater. When using Bipolar mode, associated equipment and active accessories should be selected that have a voltage rating of 1 kVp or greater. 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.

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CAUTIONS: 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 (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. 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. 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.1

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.

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 Bantam Pro 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.

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Site Condition • Clean and protect from infection from start through completion of procedure. • Note the follow Conditions of visibility for use: Site of use • Site of use: Tissue (ligament, cartilage) Ambient luminance range

100 lx to 1,500 lx

Viewing distance

20 cm to 200 cm

Viewing angle

normal to the display ± 30˚

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 Intended User Profile • Education: Trained physician, physicians assistance, clinicians - No maximum • Knowledge: - Minimum: o understands electrosurgery and electrosurgical techniques o read and understand supplied “User’s Guide” (accompanying document) o understands hygiene - No maximum • Experience: - Minimum: o Some training on techniques or training under surveillance/supervision o 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

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Bovie Medical Corporation

CONTROLS, INDICATORS, AND RECEPTACLES This section describes: ● The Front, Rear, and Side Panels ● Controls, Indicators, and Receptacles

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FRONT PANEL Figure 2 – 1 Layout of controls, indicators, and receptacles on the front panel

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Bovie Medical Corporation

Symbols on the Front Panel The following table lists descriptions for symbols found on the front panel of the Bantam Pro. SYMBOLS

DESCRIPTION

Generator Controls Cut mode Blend mode Coagulation mode High Frequency Desiccator Controls Bipolar mode Micro Bipolar mode Fulguration mode Indicators, Warnings RF ground referenced to earth RF Isolated – Patient connections are isolated from earth at high frequency. Mandatory: Refer to instruction manual / guide Warning - dangerous voltage Handpiece Connectors Monopolar handpiece Patient return electrode Footswitch Bipolar forceps

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FRONT PANEL CONTROLS Figure 2 – 2 Controls and indicators for the cut, blend, coag, fulguration, bipolar, and micro bipolar modes

Active Indicators Indicates when the power is activated in Cut or Blend Mode by illuminating in yellow .

Power Output Control Knob Turn clockwise to increase power output, counterclockwise to decrease power output.

Active Indicators Indicates when the power is activated in Coagulation, Fulguration, or Bipolar Modes by illuminating in blue .

Power Display (watts) Indicates the power set for the selected mode.

Cut, Blend, Coag, Fulguration, Bipolar, Micro Bipolar Mode Indicator Indicates when mode is selected. *RF ground referenced, only applies to the fulguration mode.

Power Switch Flip toggle up to switch generator ON, flip down to switch power OFF.

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INDICATORS AND RECEPTACLES Figure 2 – 3 Indicators and receptacles

Single Plate Patient Return Electrode Indicator

Illuminates green when the system detects a single plate. Patient Return Electrode (NEM) Alarm Indicator Illuminates when the system detects a patient return electrode alarm condition.

NOTICE:

Solid pad indicator only detects that a pad is connected to the unit. The unit does not monitor pad placement on the patient.

Bipolar Cord Receptacle Accepts the Aaron A827V bipolar forceps cord.

Footswitch Receptacle Accepts the Aaron A803 footswitch cord.

Split-Plate Patient Return Electrode Indicator

Illuminates green when the system detects a split plate is properly placed on the patient.

Patient Plate Grounding Receptacle Accepts the Aaron A1252C reusable grounding cord.

Monopolar Handpiece Receptacle Accepts the Aaron A902 3-button handpiece cord.

NOTICE: A return electrode is not required for the fulguration mode. The patient plate alarm is not used for this mode. Procedures may be performed without the use of a return electrode.

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REAR AND SIDE PANELS Figure 2 – 4 Layout of controls and indicators on the rear and side panel

Symbols on the Rear and Side Panels SYMBOLS

DESCRIPTION Power Off Power On Caution Volume Control ✱ Do not dispose of this device in the unsorted municipal waste stream. Caution, Consult Accompanying Documents Manufacturer Conforms to European Union medical Directives 93/42/ECC and its revision 2007/47/EC. Compliant RoHS Directive (2011/65/EU). Fuse Symbol (bottom panel, not pictured) 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: 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.

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