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Related Manuals for Bovie SPECIALIST PRO
Summary of Contents for Bovie SPECIALIST PRO
- Page 1 SPECIALIST | PRO Electrosurgical Generator User’s Guide...
- Page 2 USER’S GUIDE User’s Guide • Specialist | PRO...
- Page 3 Bovie Medical Corporation...
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Page 4: Preface
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 per- mission of Bovie Medical Corporation. Bovie® Part Number MC-55-237-001_4-EN CONVENTIONS USED IN THIS GUIDE... -
Page 5: Table Of Contents
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 Bovie Medical Corporation... - Page 6 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 –...
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Page 7: List Of Figures
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 Bovie Medical Corporation... -
Page 8: Section 1 - Introducing The Specialist | Pro Electrosurgical Generator
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. -
Page 9: Indications For Use
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. -
Page 10: Components And Accessories
COMPONENTS AND ACCESSORIES To avoid incompatibility and unsafe operation, we recommend using the following Bovie brand accessories supplied with your generator: • One disposable pencil - ESP1-S • Specialist | PRO Electrosurgical Generator • Hospital-grade power cords - 09-039-001; 09-035-001 •... - Page 11 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...
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Page 12: Cautions
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. -
Page 13: Contraindications
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. Bovie Medical Corporation... - Page 14 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...
- Page 15 Bovie Medical Corporation...
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Page 16: Section 2 - Controls, Indicators, And Receptacles
CONTROLS, INDICATORS, AND RECEPTACLES This section describes: ● The Front and Rear Panels ● Controls, Indicators, Receptacles, the Fuse Drawer, and Ports User’s Guide • Specialist | PRO... -
Page 17: Front Panel
FRONT PANEL Figure 2 – 1 Layout of controls, indicators, and receptacles on the front panel Bovie Medical Corporation... -
Page 18: Symbols On The Front Panel
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 –... -
Page 19: Cut And Blend Controls
When pressed, selects the Blend Mode. Cut and Blend Power Control Buttons Increases (top button) or decreases Blend Indicator (lower button) the Cut or Blend power Illuminates when output in increments of 1 watt. Blend Mode is selected. Bovie Medical Corporation... -
Page 20: Coag And Bipolar Controls
COAG AND BIPOLAR CONTROLS Figure 2 – 3 Controls for the Coagulation, Fulguration, and Bipolar Modes Coag and Bipolar Coag and Bipolar Power Display (watts) Activation Indicator Indicates the power set for Illuminates when you any Coag or Bipolar Mode. Coagulation Indicator activate Coagulation, Illuminates when... -
Page 21: Indicators
NOTICE: Only detects that the attached electrode is connected to the unit. The unit does not monitor electrode placement on the patient. Bovie Medical Corporation... -
Page 22: Power Switch And Receptacles
Power On/Off Switch Monopolar Footswitching Receptacle Bipolar Receptacle Turns the unit on or off. Accepts cable or adapter equipped with Accepts standard cable Bovie plug. Connect footswitching for bipolar handpieces. accessories. User’s Guide • Specialist | PRO... -
Page 23: Rear Panel
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, cer- tain electronic products must be returned directly to Bovie Medical Corporation. Contact your Bovie® sales representative for return instructions. -
Page 24: Section 3 - Getting Started
GETTING STARTED This section includes the following information: ● Initial Inspection ● Installing the Unit ● Checking Unit Functions ● Testing Unit Performance User’s Guide • Specialist | PRO... -
Page 25: Initial Inspection
3. Connect a two-pedal footswitch to the mating footswitch receptacle on the back of the unit. Only Bovie Brand footswitches are approved for use with the Specialist | PRO. Although other types of footswitches may fit, they may not be compatible. -
Page 26: Confirming Modes
CONFIRMING MODES Confirm that you can select each mode and adjust the power up and down. Checking Bipolar Mode (with Footswitch) 1. Select Bipolar mode by pressing the Bipolar Mode Selector. 2. Select Bipolar Footcontrol by pressing the Footcontrol Selector. 3. - Page 27 Bovie Medical Corporation...
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Page 28: Section 4 - Using The Specialist | Pro Electrosurgical Generator
USING THE SPECIALIST | PRO ELECTROSURGICAL GENERATOR This section contains the following procedures: ● Inspecting the Generator and ccessories ● Setup Safety ● Setting Up ● Preparing for Monopolar Surgery ● Preparing for Bipolar Surgery ● ctivation Safety ● ctivating the Unit CAUTIONS Read all warnings, cautions, and instructions provided with this generator before use. -
Page 29: Inspecting The Generator And Accessories
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. Bovie Medical Corporation... -
Page 30: Cautions
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. -
Page 31: Notices
PREPARING FOR MONOPOLAR SURGERY Monopolar surgery requires a patient return electrode. Applying the Return Electrode To maximize patient safety, Bovie Medical Corporation recommends using a split return electrode and a Bovie® generator with a contact quality monitoring system (Bovie NEM™). NOTICE: The Bovie NEM™... -
Page 32: Connecting Accessories
Before activation, pad placement and visual verification of the split return electrode (split pad) indi- cator on the front panel is recommended. After connecting the split pad to the generator and plac- ing the split pad securely to the patient, give the unit 3 seconds to recognize the split pad. The split pad indicator will illuminate green. -
Page 33: Cautions
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. Bovie Medical Corporation... -
Page 34: Activating The Unit
When not using active accessories, place them in a holster or in a clean, dry, non-conductive, and highly visible area not in contact with the patient. Inadvertent contact with the patient may result in burns. 1. U.S. Department of Health and Human Services. National Institute for Occupational Safety and Health (NIOSH). - Page 35 Bovie Medical Corporation...
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Page 36: Section 5 - Maintaining The Specialist | Pro Electrosurgical Generator
MAINTAINING THE SPECIALIST | PRO ELECTROSURGICAL GENERATOR This section covers the following topics: ● Cleaning ● Periodic Inspection ● Fuse Replacement User’s Guide • Specialist | PRO... -
Page 37: Cleaning
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. -
Page 38: Section 6 - Troubleshooting
TROUBLESHOOTING This section includes Error Code Descriptions and actions to take to resolve them. User’s Guide • Specialist | PRO... -
Page 39: Error Codes
Bipolar be stuck. 4. If the error code reappears, record the number and call display) Bovie® Customer Service. Cut and Coag buttons activated The unit does not allow simultaneous activation of the cut and coagula- simultaneously tion modes. Release either the cut or coag button on the handpiece, or (pencil or footswitch) the cut or coag pedal on the footswitch. -
Page 40: Section 7 - Repair Policy And Procedures
REPAIR POLICY AND PROCEDURES Refer to this section for information on: ● The Manufacturer’s Responsibility ● Returning the Generator for Service ● Returning Circuit Boards ● Finding Service Centers User’s Guide • Specialist | PRO... -
Page 41: Responsibility Of The Manufacturer
B. Be sure the generator is completely dry before you pack it for shipment. Package it in its original shipping container, if available. C. Ship the generator, prepaid, to the address given to you by the Bovie Medical Corporation Service Center. Bovie Medical Corporation... -
Page 42: Technical Specifications
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. User’s Guide •... -
Page 43: Performance Characteristics
-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... -
Page 44: Audio Volume
Audio Volume The audio levels stated below are for activation tones (bipolar, cut and coag) and alarm tones (return electrode and system alarms) at a distance of one meter. Alarm tones meet the requirements for IEC 60601-2-2. Activation Tone Volume (adjustable) 40 to >... -
Page 45: High Frequency (Rf) Leakage Current
The Specialist | PRO complies with the appropriate IEC 60601-1-2 and IEC 60601-2-2 specifications regarding electromagnetic compatibility. Voltage Transients (Emergency Generator Mains Transfer) The Specialist | PRO operates in a safe manner when the transfer is made between line AC and an emergency generator voltage source. Bovie Medical Corporation... -
Page 46: Emc Compliance
Bovie Medical. Otherwise, degradation of the performance of Specialist | Pro could result. Understand that only the Accessories supplied with or ordered from Bovie Medical should be used with your device. The Specialist | Pro and its accessories are not suitable for interconnection with other equipment. -
Page 47: Output Characteristics
7.7 ± 20% Bipolar 30 W @ 200 520 kHz 32 kHz ± 5 kHz 1200V 6.9 ± 20% (-14 kHz, +29 kHz) * an indication of a waveform's ability to coagulate bleeders without a cutting effect Bovie Medical Corporation... -
Page 48: Figure A - 1 Output Voltage Vs Power Setting (Cut, Coag)
OUTPUT POWER CURVES Figure A–1 and A–2 illustrates output voltage (Vpeak) versus power setting. Figure A–3 illustrates output power versus power setting for all modes. Figures A–4 through A–8 illustrate specific output power delivered to a range of load resistances for each mode. Figure A –... -
Page 49: Figure A - 3 Output Power Vs Power Settings For All Modes
Figure A – 3 Output power versus power setting for all modes Figure A – 4 Output power vs impedance for Cut mode Bovie Medical Corporation... -
Page 50: Output Power Curves
Figure A – 5 Output power vs impedance for Blend mode Figure A – 6 Output power versus impedance for Coagulation modes User’s Guide • Specialist | PRO... -
Page 51: Figure A - 7 Output Power Vs Impedance For Fulguration Mode
Figure A – 7 Output power versus impedance for Fulguration mode Figure A – 8 Output power vs impedance for Bipolar mode Bovie Medical Corporation... - Page 52 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 53 Notwithstanding any other provision herein or in any other document or communication, Bovie Medical Corporation’s liability with respect to this agreement and products sold hereunder shall be limited to the aggregate purchase price for the goods sold by Bovie Medical Corporation to the customer.
- Page 54 Bovie Medical Corporation 5115 Ulmerton Road Clearwater, FL 33760 USA BovieMedical.com • Sales@BovieMed.com U.S. & Canada Phone +1 800-251-3000 • Int’l. Phone +1 615-964-5532 Emergo Europe MC-55-237-001_4-EN Prinsessegracht 20 2019-03-14 2514 AP, The Hague The Netherlands...
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