SPECIALIST PRO Users Guide March 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 Specialist│PRO only. Additional technical information is available in the Specialist│PRO Service Guide. For the latest information and technical bulletins, visit www.boviemed.com.

Equipment Covered in this Manual User’s Guide • Specialist│PRO Reference No.: A1250S

For Information Contact

Bovie Medical • Clearwater, FL 33760-4004 U.S. & Canada Phone +1 800-251-3000 • Int’l. Phone +1 615-964-5532 BovieMedical.com • [email protected] Emergo Europe Prinsessegracht 20 2514 AP, The Hague The Netherlands Printed in USA ©2019 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-55-237-001_4-EN

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 Preface ...3 Equipment Covered in this Manual ...3 For Information Contact ...3 Conventions Used in this Guide ...3 List of Figures...6 Section 1 – Introducing the Specialist | PRO Electrosurgical Generator...7 Indications for Use ...8 Operating Principles ...8 Intended Use ...8 Key Features ...8 Components and Accessories...9 Safety ...9 Warnings...9 Cautions...11 Contraindications ...12 Notices ...12 Application Specifications ...12 Operating Conditions ...12 Section 2 – Controls, Indicators, and Receptacles ...15 Front Panel...16 Symbols on the Front Panel ...17 Cut and Blend Controls...18 Coag and Bipolar Controls ...19 Indicators ...20 Power Switch and Receptacles ...21 Rear Panel ...22 Symbols on the Rear Panel...22 Section 3 – Getting Started ...23 Initial Inspection...24 Installation ...24 Function Checks...24 Setting Up the Unit...24 Checking the Patient Return Electrode Alarm...24 Confirming Modes ...25 Checking Bipolar Mode (with Footswitch)...25 Checking Monopolar Mode (with Footswitch) ...25 Checking Monopolar Mode (with Handswitch) ...25 Performance Checks ...25 Section 4 – Using the Specialist | PRO Electrosurgical Generator ...27 Inspecting the Generator and Accessories...28 Setup Safety...28 Warnings ...28 Cautions ...29 Notices ...30 Setting Up...30 Preparing for Monopolar Surgery ...30

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Applying the Patient Return Electrode ...30 Connecting Accessories...31 Preparing for Bipolar Surgery ...31 Activation Safety ...31 Warnings...31 Cautions ...32 Activating the Unit...33 Notices ...33 Section 5 – Maintaining the Specialist | PRO Electrosurgical Generator ...35 Cleaning...36 Periodic Inspection ...36 Fuse Replacement ...36 Section 6 – Troubleshooting ...37 Error Codes ...38 Section 7 – Repair Policy and Procedures ...39 Responsibility of the Manufacturer...40 Returning the Generator for Service ...40 Step 1 – Obtain a Returned Goods Authorization Number...40 Step 2 – Clean the Generator...40 Step 3 – Ship the Generator...40 Appendix A - Technical Specifications ...41 Performance Characteristics ...42 Input Power ...42 Duty Cycle ...42 Dimensions and Weight ...42 Operating Parameters...42 Transport ...42 Storage ...42 Audio Volume ...43 Activation Tone ...43 Alarm Tone ...43 Return Electrode Sensing ...43 Low Frequency (50–60 Hz) Leakage Current...43 High Frequency (RF) Leakage Current ...44 Operating Conditions...44 Standards and IEC Classifications...44 Class I Equipment (IEC 60601-1)...44 Type BF Equipment (IEC 60601-1) / Defibrillator Proof...44 Drip Proof (IEC 60601-2-2) ...44 Electromagnetic Interference ...44 Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2) ...44 Voltage Transients (Emergency Generator Mains Transfer)...44 EMC Compliance...45 Output Characteristics...47 Maximum Output for Monopolar and Bipolar Modes ...48 Output Power Curves ...49

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Appendix B – Warranty ...51 The Specialist | PRO Electrosurgical Generator Warranty...51

LIST OF FIGURES Figure 2 – 1 Layout of controls, indicators, and receptacles on the front panel ...16 Figure 2 – 2 Controls for the Cut and Blend modes ...18 Figure 2 – 3 Controls for the Coagulation, Fulguration, and Bipolar modes...19 Figure 2 – 4 Indicators for power, return electrodes, and footswitch control ...20 Figure 2 – 5 Location of the unit power switch and front panel receptacles ...21 Figure 2 – 6 Layout of connectors and controls on the rear panel ...22 Figure A – 1 Output voltage vs power setting (Cut, Coag) ...47 Figure A – 2 Output voltage vs power setting (Bipolar) ...47 Figure A – 3 Output power vs power settings for all modes ...48 Figure A – 4 Output power versus impedance for Cut mode...48 Figure A – 5 Output power vs impedance for Blend mode...49 Figure A – 6 Output power vs impedance for Coagulation mode ...49 Figure A – 7 Output power vs impedance for Fulguration mode ...50 Figure A – 8 Output power vs impedance for Bipolar mode...50

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INTRODUCING THE SPECIALIST | PRO ELECTROSURGICAL GENERATOR This section includes the following information: ● Indications for Use

● Operating Principles ● Intended Use ● Key Features

● Components and Accessories ● Safety

● Contraindications

● 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.

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INDICATIONS FOR USE

The Specialist | PRO 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, contact Bovie Medical Corporation.

OPERATING PRINCIPLES

The Specialist | PRO 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 controlled output and bipolar foot controlled output.

INTENDED USE

The Specialist | PRO Electrosurgical Generator is intended to be used for all electrosurgical cut, blend, coagulation, fulguration and bipolar procedures. NOTICE: The Specialist | PRO is not intended for Tubal Ligation.

KEY FEATURES The Specialist | PRO Electrosurgical Generator includes the latest technology. This unit offers unsurpassed performance, 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. • Memory The unit automatically powers up to the last selected modes and power settings. • Isolated RF output This minimizes the potential of alternate site burns. • Standard connectors These connectors accept the latest monopolar and bipolar instruments. • Self diagnostics These diagnostics continually monitor the unit to ensure proper performance. • Return electrode sensing and contact quality monitoring The Specialist | 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.

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COMPONENTS AND ACCESSORIES

To avoid incompatibility and unsafe operation, we recommend using the following Bovie® brand accessories supplied with your generator: • Specialist | PRO Electrosurgical Generator • Hospital-grade power cords - 09-039-001; 09-035-001 measuring 15 feet (4.572 meters) • User’s Guide (s)

ADDITIONAL ACCESSORIES

• One disposable pencil - ESP1-S • Three electrodes - ES20 (ball); ES02 (needle); ES01 (blade) • One reusable grounding cord - A1252C measuring 9.85 feet (3 meters) • Five disposable split grounding pads -ESRE-1 • ESU Series I DVD

To avoid incompatibility and unsafe operation, we recommend using the following Bovie® accessories with the Specialist│PRO: • 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 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 Specialist | 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 Specialist | 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. 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. No modification of this equipment is allowed.

Electric Shock Hazard - Connect the generator power cord to a properly grounded receptacle. Do not use power plug adapters. Electric Shock Hazard - Always turn off and unplug the generator before cleaning. Fire Hazard - Do not use extension cords. Patient Safety - Use the generator only if the self-test has been completed as described.

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Otherwise, inaccurate power outputs may result. Failure of the high frequency electrosurgical equipment could result in an unintended increase of output power. The instrument receptacles on this generator are designed to accept only one instrument at a time. Do not attempt to connect more than one instrument at a time into a given receptacle. Doing so will cause simultaneous activation of the instruments. Use the lowest output setting necessary to achieve the desired surgical effect. Use the active electrode only for the minimum time necessary in order to lessen the possibility of unintended burn injury. Pediatric applications and/or procedures performed on small anatomic structures may require reduced power settings. The higher the current flow, and the longer the current is applied, the greater the possibility of unintended thermal damage to tissue, especially during use on small structures. 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. 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. 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. 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 Specialist | PRO 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. 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 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 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. Do not use electrosurgical equipment unless properly trained to use it in the specific procedure

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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. 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. 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 nitrous oxide (N20) 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 (contact quality monitor) 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 (contact quality monitor) 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.

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

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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 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.

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. 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.

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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

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 • Clean and protect from infection from start through completion of procedure. • Note the follow Conditions of visibility for use: - Ambient luminance range: 100 lx to 1,500 lx - Viewing distance: 20 cm to 200 cm Ambient luminance range

100 lx to 1,500 lx

Viewing angle

normal to the display ± 30˚

Viewing distance

20 cm to 200 cm

Description • The Specialist | PRO Electrosurgical Generator intended to be used for all electrosurgical cut, blend, coagulation, fulguration and bipolar procedures. - Viewing angle: normal to the display ± 30°

Site of use • Site of use: Tissue (ligament, cartilage) 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

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CONTROLS, INDICATORS, AND RECEPTACLES This section describes: ● The Front and Rear Panels ● Controls, Indicators, Receptacles, the Fuse Drawer, and Ports

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

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SYMBOLS ON THE FRONT PANEL SYMBOLS

DESCRIPTION

Cut Controls Cut Mode Blend Mode Coag Controls Coagulation Mode Fulguration Mode Bipolar Controls Bipolar Mode Indicators Solid Return Electrode Split Return Electrode Regulatory Symbology Mandatory: Refer to instruction manual/guide Defibrillator Proof Type BF Equipment RF Isolated – patient connections are isolated from earth at high frequency. Warning: Dangerous voltage. Power Switch and Handpiece Connectors Patient Return Electrode Monopolar Output Bipolar Output

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CUT AND BLEND CONTROLS Figure 2 – 2 Controls for the Cut and Blend Modes

Cut Indicator Illuminates when Cut Mode is selected.

Cut and Blend Power Display (watts) Indicates the power set for the Cut or Blend Mode.

Cut and Blend Activation Indicator Illuminates when you activate either Cut or Blend Mode.

Cut Selector When pressed, selects the Cut Mode.

Blend Selector When pressed, selects the Blend Mode.

Blend Indicator Illuminates when Blend Mode is selected.

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Cut and Blend Power Control Buttons Increases (top button) or decreases (lower button) the Cut or Blend power output in increments of 1 watt.

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COAG AND BIPOLAR CONTROLS Figure 2 – 3 Controls for the Coagulation, Fulguration, and Bipolar Modes

Coagulation Indicator Illuminates when Coagulation Mode is selected.

Coag and Bipolar Power Display (watts) Indicates the power set for any Coag or Bipolar Mode.

Coag and Bipolar Activation Indicator Illuminates when you activate Coagulation, Fulguration, or Bipolar Mode.

Coagulation Selector When pressed, selects the Coagulation Mode.

Fulguration Indicator Illuminates when Fulguration Mode is selected.

Fulguration Selector When pressed, selects the Fulguration Mode.

Bipolar Selector When pressed, selects the Bipolar Mode.

Bipolar Indicator Illuminates when Bipolar Mode is selected.

User’s Guide • Specialist | PRO

Coag and Bipolar Power Control Buttons Increases (top button) or decreases (lower button) the Coag or Bipolar power output in increments of 1 watt.

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INDICATORS Figure 2 – 4 Indicators for power, return electrodes, and footswitch control

Monopolar Footswitch Control Indicator Illuminates when monopolar footswitch control is selected.

Power Indicator Illuminates when the unit is on.

Split Return Electrode Indicator Illuminates green when the system detects a split plate is properly placed on the patient.

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Single Plate (Solid) Patient Return Electrode Indicator Illuminates green when the system detects a single plate.

Patient Return Electrode Alarm Indicator Illuminates when the system detects a patient return electrode alarm condition.

Bipolar Footswitch Control Indicator Illuminates when bipolar footswitch control is selected.

Footswitch Control Selector When pressed, toggles between monopolar and bipolar foot control.

NOTICE: Only detects that the attached electrode is connected to the unit. The unit does not monitor electrode placement on the patient.

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