Bovie SPECIALIST PRO User Manual
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SPECIALIST | PRO
Electrosurgical Generator
User’s Guide
USER’S GUIDE
User’s Guide • Specialist | PRO 1
2 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.
User’s Guide • Specialist | PRO 3
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
4 Bovie Medical Corporation
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
User’s Guide • Specialist | PRO 5
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
6 Bovie Medical Corporation
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.
User’s Guide • Specialist | PRO 7
8
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.
Bovie Medical Corporation
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
• 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
ADDITIONAL ACCESSORIES
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 [N
2
0] 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.
User’s Guide • Specialist | PRO 9
10
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
Bovie Medical Corporation
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 (N
2
0) 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
User’s Guide • Specialist | PRO 11
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.
12 Bovie Medical Corporation
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
Viewing distance
Viewing angle
100 lx to 1,500 lx
20 cm to 200 cm normal to the display ± 30˚
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
User’s Guide • Specialist | PRO 13
14 Bovie Medical Corporation
CONTROLS, INDICATORS, AND RECEPTACLES
This section describes:
●
The Front and Rear Panels
●
Controls, Indicators, Receptacles, the Fuse Drawer, and Ports
User’s Guide • Specialist | PRO 15
FRONT PANEL
Figure 2 – 1 Layout of controls, indicators, and receptacles on the front panel
16 Bovie Medical Corporation
SYMBOLS ON THE FRONT PANEL
SYMBOLS
Cut Controls
DESCRIPTION
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
User’s Guide • Specialist | PRO 17
CUT AND BLEND CONTROLS
Figure 2 – 2 Controls for the Cut and Blend Modes
Cut Selector
When pressed, selects the Cut
Mode.
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.
Blend Selector
When pressed, selects the Blend Mode.
Blend Indicator
Illuminates when
Blend Mode is selected.
18
Cut and Blend Power Control Buttons
Increases (top button) or decreases
(lower button) the Cut or Blend power output in increments of 1 watt.
Bovie Medical Corporation
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.
Coag and Bipolar Power Control Buttons
Increases (top button) or decreases (lower button) the Coag or Bipolar power output in increments of
1 watt.
User’s Guide • Specialist | PRO 19
INDICATORS
Figure 2 – 4 Indicators for power, return electrodes, and footswitch control
Power Indicator
Illuminates when the unit is on.
Monopolar Footswitch
Control Indicator
Illuminates when monopolar footswitch control is selected.
Bipolar Footswitch
Control Indicator
Illuminates when bipolar footswitch control is selected.
Split Return
Electrode Indicator
Illuminates green when the system detects a split plate is properly placed on the patient.
Single Plate (Solid) Patient
Return Electrode Indicator
Illuminates green when the system detects a single plate.
NOTICE:
Only detects that the attached electrode is connected to the unit. The unit does not monitor electrode placement on the patient.
Patient Return Electrode
Alarm Indicator
Illuminates when the system detects a patient return electrode alarm condition.
Footswitch Control
Selector
When pressed, toggles between monopolar and bipolar foot control.
20 Bovie Medical Corporation
POWER SWITCH AND RECEPTACLES
Figure 2 – 5 Location of the unit power switch and front panel receptacles
Patient Return Electrode
Receptacle
Accepts a standard patient return electrode plug.
Monopolar Handswitching Receptacle
Accepts standard three-pin handpiece.
Connect handswitching accessories.
Power On/Off Switch
Turns the unit on or off.
Monopolar Footswitching Receptacle
Accepts cable or adapter equipped with
Bovie plug. Connect footswitching accessories.
Bipolar Receptacle
Accepts standard cable for bipolar handpieces.
User’s Guide • Specialist | PRO 21
REAR PANEL
Figure 2 – 6 Layout of connectors and controls on the rear pan
SYMBOLS ON THE REAR PANEL
SYMBOLS DESCRIPTION
Equipotential Ground Stud
Caution
Volume Control
Fuse Enclosed
✱ Do not dispose of this device in the unsorted municipal waste stream.
Footswitch Input Jack
Read Instructions Before Use
Manufacturer
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.
22 Bovie Medical Corporation
GETTING STARTED
This section includes the following information:
●
Initial Inspection
●
Installing the Unit
●
Checking Unit Functions
●
Testing Unit Performance
User’s Guide • Specialist | PRO 23
INITIAL INSPECTION
When you first unpack your Specialist | PRO Electrosurgical Generator, inspect it visually:
1. Look for any signs of damage.
2. Verify that the shipping package contains all items listed on the packing list.
If the unit or any accessories are damaged, notify Bovie® Medical’s Customer Service immediately. Do not use any damaged equipment.
INSTALLATION
Place the Specialist | PRO Electrosurgical Generator on any flat surface with a tilt angle not more than 10 degrees.
The unit relies on natural convection cooling. Do not block its bottom or rear vents. Ensure that air flows freely on all sides of the unit.
WARNING
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.
FUNCTION CHECKS
Upon initial installation of the unit, perform the following checks. Refer to the figures in the previous chapter for the location of connectors and controls.
CAUTION
At no time should you touch the active electrode or bipolar forceps. A burn could result.
SETTING UP THE UNIT
1. Verify that the Power Switch is in the Off position and that no accessories are connected to the unit.
2. Connect a hospital grade power cable to the AC power cable receptacle on the back of the unit, then to a
properly grounded wall outlet.
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.
4. Do not connect a patient return electrode at this time.
5. Turn the unit on by switching the power switch to the On position.
CHECKING THE PATIENT RETURN ELECTRODE ALARM
1. Adjust the power settings for each mode (Cut, Blend, Coagulation, Fulguration, and Bipolar) to one watt.
2. Press the Cut pedal of the footswitch. Verify that an alarm sounds for three seconds and the Patient Return
Electrode Sensing Alarm Indicator Light illuminates, indicating that you connected no patient return electrode
to the unit.
3. Verify that adjusting the volume control on the back of the unit while the alarm is sounding can not change
the alarm sound level.
24 Bovie Medical Corporation
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. Verify that the Bipolar Mode Indicator illuminates and that the system generates the Coag tone when you
press the Coag pedal on the footswitch.
4. While activating the Bipolar mode, rotate the volume control over the full range to verify that the sound is
audible throughout the range.
5. Confirm that releasing the Coag pedal returns the unit to an idle state.
Checking Monopolar Mode (with Footswitch)
1. Select monopolar foot control by pressing the Footswitch Control Selector until the Monopolar Footswitch
Control Indicator illuminates.
2. Connect a single-plate patient return electrode to the Return Electrode receptacle of the unit. Verify that the
green single-plate patient return electrode indicator illuminates.
3. Press the Cut pedal on the footswitch. Verify that the Cut and Blend Activation Indicator illuminates and that
the system generates the Cut activation tone.
4. While activating the Cut mode, rotate the volume control over the full range to verify that the sound is audible
throughout the range.
5. Press the Coag pedal on the footswitch. Verify that the Coagulation, Fulguration, and Bipolar Activation
Indicator illuminates and that the system generates the Coag activation tone.
6. While activating the Coag mode, rotate the volume control over the full range to verify that the sound is
audible throughout the range.
Checking Monopolar Mode (with Handswitch)
1. Connect a handswitching handpiece to the Monopolar Handswitching receptacle.
2. Activate, one at a time, the Cut and Coag handswitching controls. Verify that each control causes the correct
indicator and tone to sound.
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.
User’s Guide • Specialist | PRO 25
26 Bovie Medical Corporation
USING THE SPECIALIST | PRO
ELECTROSURGICAL GENERATOR
This section contains the following procedures:
●
Inspecting the Generator and Accessories
●
Setup Safety
●
Setting Up
●
Preparing for Monopolar Surgery
●
Preparing for Bipolar Surgery
●
Activation Safety
●
Activating the Unit
CAUTIONS
Read all warnings, cautions, and instructions provided with this generator before use.
Read the instructions, warnings, and cautions provided with electrosurgical accessories before use. Specific instructions are not included in this manual.
User’s Guide • Specialist | PRO 27
INSPECTING THE GENERATOR AND ACCESSORIES
Before each use of the Specialist | PRO Electrosurgical Generator, 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 power cord (110V or 220V), 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.
SETUP SAFETY
WARNINGS:
Hazardous Electrical Output - This equipment is for use only by trained, licensed physicians.
Electric Shock Hazard - Connect the generator power cord to a properly grounded receptacle. Do not use power plug adapters.
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.
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.
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.
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.
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.
28 Bovie Medical Corporation
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.
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 (N
2
O) 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.
Proper application and visual inspection of the patient return electrode is required for safe operation.
CAUTIONS:
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.
Non-function 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.
User’s Guide • Specialist | PRO 29
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.
NOTICES:
If required by local codes, connect the generator to the hospital equalization connector with an equipotential cable.
Connect the power cord to a wall outlet having the correct voltage. Otherwise, product damge may result.
SETTING UP
1. Verify that the generator is Off by pressing the power switch Off (O).
2. Place the generator on a stable flat surface, such as a table, platform, or medical cart.
Carts with conductive wheels are recommended. For details, refer to the procedures for your institution or to
local codes. Provide at least four to six inches of space from the sides and top of the generator for cooling.
Normally, the top, sides, and rear panel are warm when you use the generator continuously for extended
periods of time.
3. Plug the generator power cord into the AC Power Cable Receptacle on the rear panel.
4. Plug the generator power cord into a grounded receptacle.
5. Turn on the generator by pressing the power switch On (|). Verify the following:
• All visual indicators and displays on the front panel illuminate.
• Activation tones sound to verify that the speaker is working properly.
6.
If the self-test is successful , a tone sounds. Verify the following:
• A Cut mode is selected; a Coag or Bipolar mode is selected.
• Each display shows a power setting. The unit automatically powers up to the Cut and Coag modes and their
last selected power settings.
• The Patient Return Electrode Alarm Indicator illuminates red.
If the self-test is not successful , an alarm tone sounds. An error code may appear in the Cut display and/or the Coag display, in most cases, the generator is disabled. Note the error code and refer to SECTION 6,
TROUBLESHOOTING .
Once the self-test is successful, connect the accessories and set the generator controls. Refer to PREPARING FOR
MONOPOLAR SURGERY or PREPARING FOR BIPOLAR SURGERY later in this section.
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™ system recommends that you use a split return electrode.
30 Bovie Medical Corporation
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.
Refer to the manufacturer’s instructions for application site and placement procedures. When using metal plate patient return electrodes, use a conductive gel specifically designed for electrosurgery. Select a patient return electrode site with good blood flow. While a properly applied electrode results in minimal tissue heating beneath the electrode, a good blood flow helps carry heat away from the site.
Connect the cable to the Patient Return Electrode Receptacle on the front of the unit.
Connecting Accessories
1. Connect a monopolar active electrode to the unit:
If you are using…
Standard 3-pin handswitching pencil
Footswitching pencil
Connect it to…
Monopolar Handswitching Receptacle
Monopolar Footswitching Receptacle
2. If using a footswitch activated device, connect the footswitch (Item #9006525) to the footswitch connecting
socket on the rear of the unit.
PREPARING FOR BIPOLAR SURGERY
1. Select the Bipolar Mode, by pressing the Bipolar Mode Selector. The Bipolar Mode Indicator will illuminate.
2. Select Bipolar Footcontrol by pressing the Footcontrol Selector.
3. Connect a Bipolar cable to the Bipolar Receptacle.
4. Connect the footswitch to the footswitch connecting socket on the rear of the unit.
5. Connect a forceps instrument to the Bipolar cable.
ACTIVATION SAFETY
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.
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.
Danger: Fire / Explosion Hazard - Do not use the Specialist | PRO 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 that may accumulate in body cavities such as the bowel
• Oxygen enriched atmospheres
• Oxidizing agents (such as nitrous oxide [N
2
O] 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.
User’s Guide • Specialist | PRO 31
32
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.
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.
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.
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.
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 jewelry from the patient before activation.
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
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.
Bovie Medical Corporation
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). Control of Smoke from Laser / Electric Surgical Procedures. HAZARD
CONTROLS, Publication No. 96-128, September, 1996.
ACTIVATING THE UNIT
When you turn on your unit, remember this feature:
• Specialist | PRO Electrosurgical Generator will power up to the last selected modes and power settings. For
example, if you set Cut mode at 50 watts when you turned the unit off, it will automatically return to
Cut mode at 50 watts when you turn it on again. Similarly, if you set Coagulation mode at 40 watts before you
turned the unit off, it will return to Coagulation mode at 40 watts when you turn it on again.
1. Monopolar Cut - Select the mode of operation for cut: Cut or Blend, then Select the desired Cut power settings
by pressing the Cut and Blend Power Control Buttons.
2. Monopolar Coag - Select the mode of operation for coagulation: Coagulation or Fulguration, then Select the
coagulation power settings by pressing the Coagulation, Fulguration, and Bipolar Power Control Buttons.
3. Bipolar - Select the mode of operation for Bipolar, then select the Bipolar power settings by pressing the
Coagulation, Fulguration, and Bipolar Power Control Buttons.
4. Activate the generator by pressing the appropriate button. For Monopolar activation, activate the generator by
pressing the appropriate handswitch button or pedal on the footswitch. For Bipolar activation, activate the
generator by pressing the Coag (blue) footswitch pedal.
To Activate...
Monopolar
Press This...
On This Device...
Cut or Blend Modes
Coagulation or Fulguration Modes
Yellow Button
Yellow Pedal
Blue Button
Blue Pedal
Handswitching Pencil
Footswitch
Handswitching Pencil
Footswitch
Bipolar
Any Bipolar Blue (Coag) Pedal Footswitch
NOTICE
One footswitch activates either monopolar or bipolar footswitching accessories.
User’s Guide • Specialist | PRO 33
34 Bovie Medical Corporation
MAINTAINING THE SPECIALIST | PRO
ELECTROSURGICAL GENERATOR
This section covers the following topics:
●
Cleaning
●
Periodic Inspection
●
Fuse Replacement
User’s Guide • Specialist | PRO 35
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.
NOTICE
Do not clean the generator with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch the panels or damage the generator.
1. Turn off the generator, and unplug the power cord from the wall outlet.
2. Thoroughly wipe all surfaces of the generator and power cord with a mild cleaning solution or disinfectant and
a damp cloth. Follow the procedures approved by your institution or use a validated infection control procedure.
Do not allow fluids to enter the chassis. Do not sterilize the generator.
PERIODIC INSPECTION
Every six months, visually inspect the Specialist | PRO Electrosurgical Generator for signs of wear or damage.
In particular, look for any of the following problems:
• Damage to the power cord
• Damage to the power cable receptacle
• Obvious damage to the unit
• Damage to any receptacle
• Accumulation of lint or debris in or around the unit.
FUSE REPLACEMENT
Fuses for the unit reside directly below the Power Cable Receptacle on the rear of the unit.
To replace the fuses, follow this procedure:
1. Unplug the power cord from the wall outlet.
2. Remove the power cord from the Power Cable Receptacle on the rear panel.
3. To release the fuse drawer, insert a small flathead screwdriver into the slot
on the drawer below the power cord receptacle. Then, slide the drawer out.
4. Remove the two fuses (T3.15AL250V) and replace them with new fuses with the same values.
5. Insert the fuse holder into the Power Cable Receptacle.
NOTICE:
If the unit does not display an error and does not power on, check fuses.
36
Fuse Holder
Bovie Medical Corporation
TROUBLESHOOTING
This section includes Error Code Descriptions and actions to take to resolve them.
User’s Guide • Specialist | PRO 37
The Specialist | PRO Electrosurgical Generator includes automatic self-diagnostics. . If the diagnostics detect an error or fault, the system displays an appropriate code, sounds an audible tone, and deactivates the unit output power.
The following tables list the codes, describes the errors or faults, and recommends actions from what is listed below to take to resolve the error or fault.
If the unit displays any other error code, it requires service.
Error Code Description
F1 (on the
Cut / Blend display)
Handswitch or monopolar footswitch cut pedal may be stuck.
F1 (on the
Coagulation /
Fulguration
Bipolar display)
Handswitch or monopolar footswitch coag pedal may be stuck.
Recommended Action
1. Turn off, then turn on the generator. Do not press buttons or activate
accessory devices during the self-test.
2. If the error code reappears, disconnect all accessories.
Turn off, then turn on the generator again.
3. If the problem persists, replace the handpiece or footswitch
and repeat the restart.
4. If the error code reappears, record the number and call
Bovie® Customer Service.
F2
Cut and Coag buttons activated simultaneously
(pencil or footswitch)
The unit does not allow simultaneous activation of the cut and coagulation modes. Release either the cut or coag button on the handpiece, or the cut or coag pedal on the footswitch.
F3
E4
E6
E7
E8
Footswitch Cut (Yellow) pedal is pressed while Bipolar Mode is selected and Footswitch Control
Selector is set to Bipolar Foot
Control. Or, Coag (Blue) pedal is pressed while Bipolar Footswitch
Control is selected and Bipolar
Mode is not selected.
Use the Footswitch Control Selector to toggle and select the Bipolar Foot
Control. Verify the Bipolar Footswitch Control Indicator
Illuminates. Use only the Coag (Blue) pedal on the footswitch.
DC voltage error
Delta error
Internal temperature of the unit exceeded the limit.
Connector Sense Error
The unit shall monitor the connection of the main cable between the main and display boards.
1. Turn the unit off.
2.Turn the unit on.
3. If the error code reappears, record the number and contact
Bovie® Customer Service.
1. Turn the unit off.
2. Verify that the unit is connected to the line voltage.
3. If the error code reappears, record the number and contact
Bovie® Customer Service.
1. Turn the unit off.
2. Allow the unit to cool for 20 minutes.
3. Turn the unit on.
4. If the error code reappears, record the number and contact
Bovie® Customer Service.
1. If this cable becomes disconnected an E8 error shall occur and be
displayed.
2. The unit cannot be activated while the error condition is present.
3. The unit has to be reset to remove the error condition.
38
NOTICE:
If the unit does not power on to display an error, check fuses as described in Section 5 of this guide.
Bovie Medical Corporation
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 39
RESPONSIBILITY OF THE MANUFACTURER
Bovie® Medical 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 manual.
• Persons authorized by Bovie® Medical 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.
• Equipment use is in accordance with the Bovie® Medical instructions for use.
For warranty information, refer to APPENDIX B - WARRANTY .
RETURNING THE ELECTROSURGICAL GENERATOR
FOR SERVICE
Before you return the generator, contact Bovie® Medical Customer Service for assistance. If instructed to send the generator to Bovie® Medical, first obtain a Returned Materials Authorization Number. Then clean the Generator and ship it to Bovie® Medical for service.
Step 1 – Obtain a Returned Materials Authorization Number
Call the Bovie® Medical Customer Service to obtain a Returned Materials Authorization Number.
Have the following information ready when you call:
• Hospital / clinic name / physician name
• Distributor whom purchased from
• Telephone number
• Department / address, city, state, and zip code
• Model number
• Serial number / Lot number
• Description of the problem
• Type of repair to be done
Step 2 – Clean the Generator
WARNING
Electric Shock Hazard - Always turn off and unplug the generator before cleaning.
NOTICE
Do not clean the generator with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch the panels or damage the generator.
A. Turn off the generator, and unplug the power cord from the wall outlet.
B. Thoroughly wipe all surfaces of the generator and power cord with a mild cleaning solution or disinfectant and
a damp cloth. Follow the procedures approved by your institution or use a validated infection control procedure.
Do not allow fluids to enter the chassis. You cannot sterilize the generator.
Step 3 – Ship the Generator
A. Attach a tag to the generator that includes the Returned Materials Authorization Number and the information
(hospital, phone number, etc.) listed in Step 1 – Obtain a Returned Materials Authorization Number .
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.
40 Bovie Medical Corporation
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 • Specialist | PRO 41
PERFORMANCE CHARACTERISTICS
Input Power
100 – 240 VAC
Mains line frequency range (nominal): 50 – 60 Hz
Power consumption: 270 VA
Fuses (two): 3.15A (Slow Blow)
Duty Cycle
Under maximum power settings and rated load conditions (Cut, 120 watt @ 500 ohm load), the generator is suitable for activation times of 10 seconds on, 30 seconds off for one hour.
The internal temperature of the unit is continuously monitored. If the temperature rises above 85 0 C, the alarm will sound and output power will be deactivated.
Dimensions and Weight
Width 26 cm (10.25 in.)
Height 15.2 cm (6 in.)
Depth
Weight
30.5 cm (12 in.)
< 4 kg (< 9 lbs)
Operating Parameters
Ambient temperature range
Relative humidity
Atmospheric pressure
Warm-up time
Transport
Ambient temperature range
Relative humidity
Atmospheric pressure
Storage
Ambient temperature range
Relative humidity
Atmospheric pressure
10° to 40° C (50° to 104° F)
30% to 75%, non-condensing
70kPa to 106kPa
If transported or stored at temperatures outside the operating temperature range, allow one hour for the generator to reach room temperature before use.
-40˚ to +70˚ C
10% to 100%, including condensation
50kPa to 106kPa
10˚ to 30˚ C (68˚ to 86˚ F)
10% to 75%, non-condensing
5 0kPa to 106kPa
42 Bovie Medical Corporation
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 > 65 dBA
Frequency Cut: 610 Hz ± 10 Hz
Blend: 610 Hz ± 10 Hz
Pinpoint: 840 Hz ± 10 Hz
Spray: 840 Hz ± 10 Hz
Bipolar: 840 Hz ± 10 Hz
Duration Continuous while the generator is activated
Alarm Tone
Volume (not adjustable)
Frequency
65 dBA at a distance of one meter
2.44 kHz / 450 ms / 1.22 kHz / 450 ms
Return Electrode Sensing
The system presents audible and visible alarms when it senses no return electrode.
Single Plate
Trip resistance: 0
Ω
to 8
Ω
± 1
Ω
Continuous measurement:
Once the system establishes the single-plate electrode resistance, an
increase of 20
Ω
± 25
Ω
in resistance will cause an alarm. When the
alarm condition exists, the system deactivates output power.
Split Plate
Trip resistance: 10
Ω
± 5
Ω
to 135
Ω
± 10
Ω
Continuous measurement:
Once the system establishes the split-plate electrode resistance, an
increase of (35 ± 5)% in resistance will cause an alarm. When the alarm
condition exists, the system deactivates output power.
Low Frequency (50-60 Hz) Leakage Current
Enclosure source current, ground open
Source current, patient leads, all outputs
Sink current at high line, all inputs
< 500 µA 220 - 240 VAC
< 300 µA 90 - 120 VAC
Normal polarity, intact ground: < 10 µA
Normal polarity, ground open: < 50 µA
Reverse polarity, ground open: < 50 µA
< 50 µA
User’s Guide • Specialist | PRO 43
High Frequency (RF) Leakage Current
Bipolar RF leakage current
Monopolar RF leakage current (additional tolerance)
< 39 mA rms
< 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.
STANDARDS AND IEC CLASSIFICATIONS
Class I Equipment (IEC 60601-1)
Accessible conductive parts cannot become live in the event of a basic insulation failure because of the way in which they are connected to the protective earth conductor.
Type BF Equipment (IEC 60601-1) / Defibrillator Proof
The Specialist | PRO provides a high degree of protection against electric shock, particularly regarding allowable leakage currents. It is type BF equipment. Patient connections are isolated from earth and resist the effects of defibrillator discharge.
Drip Proof (IEC 60601-2-2)
The generator enclosure is constructed so that liquid spillage in normal use does not wet electrical insulation or other components which, when wet, are likely to affect adversely the safety of the generator.
Electromagnetic Interference
When other equipment is placed on or beneath an activated Specialist | PRO, the unit can be activated without interference. The generator minimizes electromagnetic interference to video equipment used in the operating room.
Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2)
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.
44 Bovie Medical Corporation
EMC COMPLIANCE
Special precautions should be taken regarding the Specialist | PRO. Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual.
WARNINGS
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and other equipment should be observed to verify that they are operating normally.
Use of accessories and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Portable RF communications (including peripherals such as antenna cables and extrenal antennas) should be used no closer than 30 cm (12 inches) to any part of the Specialist | Pro, including cables specified by 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.
The Specialist | Pro is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used in domestic purposes.
For the purposes of EN60601-1-2 the Specialist | Pro has an essential performance which is that there shall be no component failure, change in operating mode or false alarm, the delivered power shall remain within +/-20% of the set power and there shall be no reset or interruption of the HF power unless this is clearly indicated on the product.
The Specialist | Pro must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.
The Specialist | Pro is intended for use in the electromagnetic environment listed below. The customer or the user of the Specialist | Pro should assure that it is used in such an environment. - electromagnetic emissions
Emissions test Compliance Electromagnetic environment - guidance
RF Emissions CISPR 11 Group 2
The Specialist | Pro must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.
RF Emissions CISPR 11 Class A
Harmonic emissions IEC 61000-3-2 Class A
Voltage fluctuations/flicker emissions IEC 61000-3-3 Complies
The Specialist | Pro is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used in domestic purposes.
NOTICE
The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class
B is normally required) this equipment might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
User’s Guide • Specialist | PRO 45
The Specialist | Pro is intended for use in the electromagnetic environment listed below. The customer or the user of the
Specialist | Pro should assure that it is used in such an environment. - electromagnetic immunity
Immunity Test
IEC 61000-4-2, Electro-Static Discharge
IEC 61000-4-3, Radiated Immunity
IEC 61000-4-4, Electric Fast Transients Immunity 2kV, AC Mains
Compliance Test Level
±8kV Contact
±15kV Air
10V/m 80MHz – 1000MHz
10V/m 1.4GHz – 2.7GHz(1)
IEC 61000-4-5, Surge Immunity
IEC 61000-4-6, Conducted Immunity
RIEC 61000-4-8, Power Frequency Magnetic Field Immunity
IEC 61000-4-11, Voltage Dips & Interruptions
1kV Line-Line
2kV Line-PE
6Vrms, 150kHz – 80MHz
30A/m, 50 and 60Hz
<5 % UT
(>95 % dip in UT) for 0,5 cycle and 1.0 cycle
70 % UT
(30 % dip in UT) for 25/30 cycles
<5 % UT
(>95 % dip in UT) for 250/300 cycles
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.
Open Circuit
Vpeak max Mode
Cut
Blend
Coagulation
Fulguration
Bipolar
Output Power
120 W @ 500
Ω
90 W @ 800
Ω
Output Frequency
357 kHz ± 50 kHz
357 kHz ± 50 kHz
Repetition Rate
N / A
30 kHz ± 5 kHz
80 W @ 1000
Ω
40 W @ 1000
Ω
475 kHz ± 19 kHz
410 kHz ± 50 kHz
57 kHz ± 5 kHz
25 kHz ± 5 kHz
30 W @ 200
Ω
520 kHz
(-14 kHz, +29 kHz)
32 kHz ± 5 kHz
* an indication of a waveform's ability to coagulate bleeders without a cutting effect
1250V
1850V
3300V
3900V
1200V
Crest Factor*
(Rated Load)
2.9 ± 20%
3.3 ± 20%
5.5 ± 20%
7.7 ± 20%
6.9 ± 20%
46 Bovie Medical Corporation
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 – 1 Output voltage (Vpeak) versus power setting (Cut, Coag)
Figure A – 2 Output voltage (Vpeak) versus power setting (Bipolar)
User’s Guide • Specialist | PRO 47
Figure A – 3 Output power versus power setting for all modes
Figure A – 4 Output power vs impedance for Cut mode
48 Bovie Medical Corporation
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 49
Figure A – 7 Output power versus impedance for Fulguration mode
Figure A – 8 Output power vs impedance for Bipolar mode
50 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.
Bovie Medical Corporation’s obligation under this warranty is limited to the repair or replacement, at its sole option, of any product, or part thereof, which has been returned to it or its Distributor within the applicable time period shown below after delivery of the product to the original purchaser, and which examination discloses, to Bovie Medical Corporation’s satisfaction, that the product is indeed, defective.
This warranty does not apply to any product, or part thereof, which has been repaired or altered outside Bovie Medical
Corporation’s factory in a way so as, in Bovie Medical Corporation’s judgment, to affect its stability or reliability, or which has been subjected to misuse, neglect, or accident.
The warranty periods for Bovie Medical Corporation products are as follows:
• Electrosurgical Generators: Four years from date of shipment
• Mounting Fixtures (all models): Two years from date of shipment
• Footswitches (all models): One year from date of shipment
• Patient Return Electrodes: Shelf life only as stated on packaging
• Sterile Single Use Accessories: Only as stated on packaging
• Handpiece: Only as stated on packaging
User’s Guide • Specialist | PRO 51
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.
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.
Bovie Medical Corporation disclaims any liability hereunder or elsewhere in connection with the sale of this product, for indirect or consequential damages.
This warranty and the rights and obligations hereunder shall be construed under and governed by the laws of the State of
Florida, USA.
The sole forum for resolving disputes arising under or relating in any way to this warranty is the District Court of the County of
Pinellas, State of Florida, USA.
Bovie Medical Corporation, its dealers, and representatives reserve the right to make changes in equipment built and/or sold by them at any time without incurring any obligation to make the same or similar changes on equipment previously built and/or sold by them .
52 Bovie Medical Corporation
MC-55-237-001
_ 4 -EN
2019 03 14
Bovie Medical Corporation
5115 Ulmerton Road
Clearwater, FL 33760 USA
BovieMedical.com • [email protected]
U.S. & Canada Phone +1 800-251-3000 • Int’l. Phone +1 615-964-5532
Emergo Europe
Prinsessegracht 20
2514 AP, The Hague
The Netherlands

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