Bovie DERM 101 and 102 Service Guide Rev 0

SERVICE GUIDE

Service Guide • DERM 101/102

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This Service Guide and the equipment it describes are for qualified technicians who maintain and repair the Bovie® DERM 101/102 High Frequency Desiccator. Additional User information is available in the Bovie® DERM 101/102 User’s Guide. This document covers technical descriptions of the Bovie® DERM 101/102including its physical appearance, all operator controls and indications, operational specifications, component functional descriptions (module level), diagrams of the electronic circuits used, and troubleshooting guidelines (with chart comparisons). The Bovie DERM 101/102 was constructed with the highest quality components. In the unlikely event that your generator fails within two years of purchase date, Bovie Medical Corporation will warranty the product and effect factory repairs. Please refer to Appendix A, Warranty for what is covered, length of coverage, and “How to Receive a Return Authorization Number.”

Equipment Covered in this Manual Bovie DERM 101™, Bovie DERM 102™: Reference No.: DERM101, DERM102

For Information Contact Bovie Medical Corporation • 5115 Ulmerton Road, Clearwater, FL 33760 USA U.S. Phone 1-800-537-2790 Fax 1-800-323-1640 • International Phone +1-727-384-2323 Fax +1-727-347-9144 www.boviemed.com • [email protected]

DERM 101/102 Electrosurgical Desiccator: Reference No.: DERM 101, Reference No.: DERM 102 Manufactured by BovieBulgaria Ltd., Boul. Tsarigradsko shose No133, Building 3, fl.3 and fl.5, 1784 Sofia, Bulgaria, for Bovie Medical Corporation. ©2014 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-55-229-002 Rev. 0

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Bovie Medical Corporation

SAFETY PRECAUTIONS WHEN OPERATING THE GENERATOR 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. To promote the safe use of the Bovie® DERM 101/102, please refer to the User’s Guide for standard operating precautions.

APPLICABLE SAFETY STANDARDS Conforms To ANSI/AAMI STD ES60601-1 IEC STD 60601-1-6 & 60101-2-2 Certified To CAN/CSA STD C22.2 No. 60601-1

CONVENTIONS USED IN THIS GUIDE WARNING: Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION: Indicates a hazardous situation which, if not avoided, may result in minor or moderate injury.

NOTICE: Indicates an operating tip, a maintenance suggestion, or a hazard that may result in product damage.

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TABLE OF CONTENTS Equipment Covered in this Manual.............................................................................ii For Information Contact ..............................................................................................ii Safety Precautions When Operating the Generator ..........................................................iii Applicable Safety Standards..............................................................................................iii Conventions Used in this Guide ........................................................................................iii The Bovie DERM 101/102 .....................................................................................................1-1 Functional Description.....................................................................................................1-2 Unit Description...............................................................................................................1-2 Safety Precautions when Repairing the Generator.........................................................1-3 General Warnings, Cautions, and Notices ..............................................................1-3 Active Accessories ..................................................................................................1-3 Fire / Explosion Hazards .........................................................................................1-4 Generator Electric Shock Hazards..........................................................................1-4 Servicing..................................................................................................................1-4 Cleaning ..................................................................................................................1-4 Controls, Indicators and Receptacles.................................................................................2-1 Front Panel......................................................................................................................2-2 Controls and Indicators Overview ...................................................................................2-3 Coagulation and Bipolar Controls ..................................................................................2-4 Accessory Receptacles...................................................................................................2-5 Rear Panel View .............................................................................................................2-6 Front View on Wall Mount and Stand .............................................................................2-7 Side View Left and Right.................................................................................................2-8 Symbolson the Front and Rear Panels...........................................................................2-9 Technical Specifications ......................................................................................................3-1 Performance Characteristics...........................................................................................3-1 Input Power .............................................................................................................3-1 Duty Cycle ...............................................................................................................3-2 Dimensions and Weight ..........................................................................................3-2 Operating Parameters .............................................................................................3-2 Transport .................................................................................................................3-2 Storage....................................................................................................................3-2 Audio Volume ..........................................................................................................3-2 Low Frequency (50-60 Hz) Leakage Current..........................................................3-3 High Frequency (RF) Leakage Current...................................................................3-3 Standards and IEC Classifications..................................................................................3-3 Class I Equipment (IEC 60601-1) ...........................................................................3-3 Type CF Equipment (IEC 60601-1) ........................................................................3-3 Drip Proof (IEC 60601-2-2) .....................................................................................3-3 Electromagnetic Interference ..................................................................................3-3 Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2) ......................3-3 EMC Compliance ....................................................................................................3-4 Output Power Characteristics .........................................................................................3-8 Maximum Output for Bipolar and Monopolar ..........................................................3-8

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Theory Of Operation .............................................................................................................4-1 Block Diagram.................................................................................................................4-2 Functional Overview of Key Circuits ...............................................................................4-2 System Logic...................................................................................................................4-4 Bovie DERM 101/102 Control Signal Inputs and Outputs ..............................................4-4 Operating the Bovie DERM 101/102 ....................................................................................5-1 Inspecting the Generator and Accessories .....................................................................5-2 Service Personnel Safety................................................................................................5-2 Installation and Placement ..............................................................................................5-3 Functional Checks...........................................................................................................5-3 Unit Operations ...............................................................................................................5-5 Maintenance...........................................................................................................................6-1 Cleaning ..........................................................................................................................6-2 Periodic Inspection..........................................................................................................6-2 Fuse Replacement ..........................................................................................................6-2 Troubleshooting ....................................................................................................................7-1 Recommended Equipment for Troubleshooting..............................................................7-2 Troubleshooting the Bovie DERM 101/102.....................................................................7-2 Inspecting the Generator.........................................................................................7-2 Inspecting the Receptacles .....................................................................................7-2 Inspecting Internal Components..............................................................................7-3 Understanding Error Codes and Audio Tones.................................................................7-4 Correcting Common Problems........................................................................................7-5 Main Board Test Points ...................................................................................................7-8 Return Policy and Procedures.............................................................................................8-1 Responsibility of Manufacturer........................................................................................8-2 Returning the Unit for Service.........................................................................................8-2 Warranty ................................................................................................................................A-1 Board Drawings, Schematics, & Assemblies ....................................................................B-1 How to Order Parts from Bovie Medical Corporation .....................................................B-2 Bovie DERM 101/102 Design Breakdown and Drawing Reference...............................B-2 Bovie® Drawing and Schematic Package ......................................................................B-3

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LIST OF FIGURES Figure 2 – 1 Figure 2 – 2 Figure 2 – 3 Figure 2 – 4 Figure 3 – 1 Figure 3 – 2 Figure 3 – 3 Figure 3 – 4 Figure 3 – 5 Figure 3 – 6 Figure 4 – 1 Figure 5 – 1 Figure 5 – 2 Figure 6 – 1

Layout of controls, indicators, and receptacles on the front panel..................2-2 Controls for the cut, blend, and coag modes ..................................................2-4 Location of the front panel receptacles and power switch ..............................2-5 Layout of controls and labeling on the rear panel...........................................2-6 Output power versus power setting for all modes...........................................3-8 Power setting versus voltage (Vpeak) for all modes.......................................3-8 Output Power versus Load • Bipolar 100% / 50% ..........................................3-9 Bipolar Mode waveform ..................................................................................3-9 Output Power versus Load • Monopolar 100% / 50% ....................................3-10 Monopolar Mode waveform.............................................................................3-10 Functional block diagram of the Bovie DERM 101/102 system......................4-2 Installation and placement...............................................................................5-3 Unit setup ........................................................................................................5-4 Fuse.................................................................................................................6-2

SCHEMATICS AND BOARD DRAWINGS Main Board ..............................................................................................................................B-3 Logic Center ............................................................................................................................B-4 RF Amplifier Circuit .................................................................................................................B-5 Activation Sense Circuit (Hand, Foot, Power Up and Power Down) ......................................B-6 Power Supply ..........................................................................................................................B-7 ADC Measurement Circuit ......................................................................................................B-8 AC/DC SMPS Power Supply...................................................................................................B-9 Audio (Buzzer) Control Circuit...............................................................................................B-10 Printed Circuit Board Main ....................................................................................................B-11 Bovie DERM 101/102 Assembly ...........................................................................................B-12

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Bovie Medical Corporation

THE BOVIE® DERM 101/102 HIGH FREQUENCY DESICCATOR This section includes the following information: ● Functional Description ● Unit Description ● Safety Precautions When Repairing the Generator ● General Warnings, Cautions, and Notices ● Active Accessories ● Fire/Explosion Hazards ● Generator Electric Shock Hazards ● Servicing ● Cleaning

CAUTION Read all warnings, cautions, and instructions provided with this generator before using. Read the instructions, warnings, and cautions provided with electrosurgical accessories before using. Specific instructions are not included in this manual.

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FUNCTIONAL DESCRIPTION The Bovie® DERM 101/102 is a multipurpose High Frequency Desiccator for use in physician’s offices and surgi-centers. It provides unsurpassed performance, flexibility, reliability, and user convenience in one compact package. TheBovie® DERM 101/102 High Frequency Desiccator includes digital technology. This new technology is evident in the self-checking circuitry and error code readouts. The DERM 101™ unit offers monopolar electrosurgical operations. The DERM 102™ unit offers monopolar and bipolar electrosurgical operations.

The following are key advantages and benefits. Power Capabilities

Up to 10 watts of Coagulation @ 1000 Ω. Up to 10 watts of Bipolar @ 150 Ω.

Memory

The generator automatically powers up to the last power setting.

Self Diagnostics

These diagnostics continually monitor the unit to ensure proper performance. Whenever they detect a problem, medical personnel receive audible and visual alarm responses, and the output is suspended until the alarm condition is cleared.

UNIT DESCRIPTION TheBovie® DERM 101/102 High Frequency Desiccator is a self-contained unit, consisting of the main enclosure and power cord. The main components incorporated in the generator include: • FRONT PANEL COMPONENTS Dial for controlling power output; receptacles for connecting electrosurgical accessories; footswitch receptacle; and 7-segment display. • REAR PANEL COMPONENTS Volume control. • OTHER COMPONENTS Power switch (located on side of unit); power cable receptacle (located on bottom of unit); connector to A902 pencil. • INTERNAL COMPONENTS Main PCB

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SAFETY PRECAUTIONS WHEN REPAIRING THE GENERATOR Before servicing the Bovie® DERM 101/102 High Frequency Desiccator it is important that you read, understand, and follow the instructions supplied with it. Also, be familiar with any other equipment used to install, test, adjust, or repair this generator.

General Warnings, Cautions, and Notices WARNING 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. To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

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. Unit is designed to be wall mounted or mounted on a mobile stand. Provide as much distance as possible between the electrosurgical generator and other electronic equipment (such as monitors). An activated electrosurgical generator may cause electrical interference with them. Do not turn the activation tone down to an inaudible level. The activation tone alerts the surgical team when an accessory is active. No modification of this equipment is allowed.

NOTICE Connect the power cord to a wall receptacle having the correct voltage. Otherwise, product damage may result.

Active Accessories WARNINGS Shock Hazard – Do not connect wet accessories to the generator. Shock Hazard – Ensure that all accessories and adapters are correctly connected and that no metal is exposed. Associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than the maximum output voltage. 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.

CAUTIONS Accessories must be connected to the proper receptacle type. In particular, bipolar accessories must be connected to the Bipolar Instrument receptacle only. Improper connection may result in inadvertent generator 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. Refer to the accessories instructions for use for more detailed instructions. Set power levels to the lowest setting before testing an accessory.

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NOTICES To avoid incompatibility and unsafe operation, we recommend using only Bovie®/Aaron® accessories. During bipolar electrosurgery, do not activate the generator until the forceps have made contact with the patient. Product damage may occur.

Fire / Explosion Hazards WARNINGS Explosion Hazard – Do not install the generator in the presence of flammable anesthetics, gases, liquids, or objects. Fire Hazard – Do not place active accessories near or in contact with flammable materials (such as gauze or surgical drapes). Electrosurgical accessories that are activated or hot from use can cause a fire. Use a holster to hold electrosurgical accessories safely away from personnel and flammable materials. Fire Hazard – Do not use extension cords. Fire Hazard – For continued protection against fire hazard, replace fuses only with fuses of the same type and rating as the original fuse.

Generator Electric Shock Hazards WARNINGS Connect the generator power cord to a properly grounded receptacle. Do not use power plug adapters. To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Connect the power cord to a properly polarized and grounded power source with the frequency and voltage characteristics that match those listed on the back of the unit. Disconnect power cord from power source to isolate the internal circuits from the supply mains. Do not connect a wet power cord to the generator or to the wall receptacle. To allow stored energy to dissipate after power is disconnected (caps discharge) wait at least five minutes before replacing parts. Always turn off and unplug the generator before cleaning. Do not touch any exposed wiring or conductive surfaces while the generator is disassembled and energized. Never wear a grounding strap when working on an energized generator. When taking troubleshooting measurements use appropriate precautions such as using isolated tools and equipment, using the “one hand rule,” etc. Potentially lethal AC and DC voltages are present in the AC line circuitry, high voltage DC circuitry, and associated mounting and heat sink hardware described in this manual. These potentials are not isolated from the AC line. Take appropriate precautions when testing and troubleshooting this area of the generator. High frequency, high voltage signals that can cause severe burns are present in the RF output stage and in the associated mounting and heat sink hardware. Take appropriate precautions when testing and troubleshooting this area of the generator.

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Servicing CAUTIONS Read all warnings, cautions, and instructions provided with this generator before servicing. The generator contains electrostatic-sensitive components. When repairing the generator, work at a static-control workstation. Wear a grounding strap when handling electrostatic-sensitive components, except when working on an energized generator. Handle circuit boards by their nonconductive edges. Use an anti-static container for transport of electrostatic-sensitive components and circuit boards.

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.

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CONTROLS, INDICATORS, AND RECEPTACLES This section describes the front, rear, and side panels, including all controls, indicators, receptacles, and ports.

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FRONT PANEL Figure 2 – 1 Layout of controls, indicators, and receptacles on the front panel - DERM 101™

Figure 2 – 2 Layout of controls, indicators, and receptacles on the front panel- DERM 102™

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Bovie Medical Corporation

CONTROLS AND INDICATORS OVERVIEW Users may control most Bovie® DERM 101/102 functions from the front panel. Each Control is plainly marked on the front panel for quick reference. The volume control is located on the rear panel. Normal operations involve activating the generator with either a front connected handswitch or footswitch. The following components are the User Interface for the Bovie® DERM 101/102 High Frequency Desiccator: Power Switch

The rocker ON/OFF switch on the lower right corner. The switch turns power on and off to the unit.

Power Control Knob

This rotary knob allows you to select the desired RF power level for all modes of operation. The Power Control Knob moves at a graduated .1 watt per notch (incrementally) up to 10 watts.

Watts Display

The large power output display reports the generator’s output power setting from .1 to 10 watts.

Visual LED Indictors

The blue activation indicator reports when the unit is activated.

Audible Indicators

An activation tone sounds whenever the Bovie® DERM 101/102 High Frequency Desiccator is activated. The volume may be adjusted to a high or low setting. The volume adjust ment is located on the rear of the unit. An alarm siren sounds during all alarm conditions. The volume of this alarm cannot be adjusted.

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COAGULATION AND BIPOLAR CONTROLS Figure 2 – 3 Controls for the coag and bipolar modes

Coag and Bipolar Activation Indicator Illuminates when you activate Coag or Bipolar.

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

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Coag and Bipolar Power Control Dial Increases or decreases the Coag or Bipolar power output.

Bovie Medical Corporation

ACCESSORY RECEPTACLES Figure 2 – 4 Location of the front panel receptacles and power switch

Power Switch Powers the unit on or off.

Handpiece Holder Securely holds Bovie® handpiece when not in use.

Monopolar Handswitching Receptacle Accepts only Bovie handpieces.

Patient Return Electrode Receptacle Accepts only Bovie return electrode plugs designed for the DERM 101/102.

Service Guide • DERM 101/102

Bipolar Receptacle Accepts only Bovie cables for bipolar handpieces.

Footswitching Receptacle Accepts only Bovie footswitch.

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REAR PANEL VIEW Figure 2 – 5 Layout of controls and labeling on the rear panel

Figure 2 – 6 Rear view mounted on stand

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FRONT VIEW ON WALL MOUNT AND STAND Figure 2 – 7 Front view on wall mount

Figure 2 – 8 Front view on stand

SIDE VIEW LEFT AND RIGHT Figure 2 – 9 Side view right (On/Off switch and power control knob)

Figure 2 – 10

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Side view left (pencil holster)

Bovie Medical Corporation

SYMBOLS ON THE FRONT AND REAR PANELS The following table lists descriptions for symbols found on the DERM units Warning: Dangerous voltage. Caution: Read directions for use prior to using equipment. On (power: connection to the mains). Off (power: disconnection from the mains). * Do not dispose of this device in the unsorted municipal waste stream. Monopolar output jack (hand control pencil jack). Bipolar output jack. Patient Plate, for use with Monopolar modes. Footswitch jack, for foot controlled activation of monopolar (optional) and bipolar devices. Type BF Equipment. Non-ionizing radiation. Neutral Electrode referenced to earth. Volume control. Explosion Risk if used with flammable anesthetics.

Manufacturer Mandatory: Refer to instruction manual / guide Compliant RoHS Directive (2011/65/EU) Fuse type and rating. Slow blow (T), high capacity (H) Conforms to European Union medical Directives 93/42/ECC and its revision 2007/47/EC.

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Notice: *Please note that infected medical devices must be disposed of as medical/biohazard waste and cannot be included in used electronic equipment disposal/recycling programs. In addition, certain electronic products must be returned directly to Bovie Medical Corporation. Contact your Bovie® sales representative for return instructions.

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TECHNICAL SPECIFICATIONS All specifications are nominal and subject to change without notice. A specification referred to as “typical” is within ± 20% of a stated value at room temperature (25° C / 77° F) and a nominal input power voltage.

PERFORMANCE CHARACTERISTICS Input Power Input Voltage

100-240 VAC ~ ± 10%

Mains line frequency range (nominal):

50 – 60 Hz

Power consumption:

28 VA

Fuses (two):

T 400mAH, 250V

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Duty Cycle Under maximum power settings and rated load conditions (Coagulation 10 W @ 1000 Ω load), the generator is suitable for activation times of 10 seconds on, 30 seconds off for one hour. NOTICE The internal temperature of the unit is constantly being monitored. If the temperature rises above 75°C an alarm sounds, the system displays an error code, and the system disables output power.

Dimensions and Weight Width

20.8 cm (8.2 in.)

Depth

6.9 cm (2.7 in.)

Height

18.4 cm (7.2 in.)

Weight

< 1.4 kg (< 3 lbs.)

Operating Parameters Ambient temperature range

10° to 40° C

Relative humidity

30% to 75%, non-condensing

Atmospheric pressure

70kPa to 106kPa

Warm-up time

If transported or stored at temperatures outside the operating temperature range, allow one hour for the generator to reach room temperature before use.

Transport Ambient temperature range

-40˚ to +70˚ C

Relative humidity

10% to 100%, including condensation

Atmospheric pressure

50kPa to 106kPa

Storage Ambient temperature range

10˚ to 30˚ C

Relative humidity

10% to 75%, non-condensing

Atmospheric pressure

70kPa to 106kPa

Audio Volume The audio levels stated below are for the activation tone (bipolar and monopolar) and the alarm tone at a distance of one meter. Audio levels meet the requirements for IEC 60601-2-2. Activation Tone Volume (adjustable)

40 to 65 dB

Frequency

All Modes: 833Hz +/- 25Hz

Duration

Continuous while the generator is activated

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Alarm Tone Volume (adjustable)

40 – 60 dB

Frequency

2.44 kHz +/- 25Hz 1⁄2 seconds / 1.22kHz +/- 25Hz 400-500ms 1⁄2 seconds

Duration

Continuous while the error or fault condition is present

Low Frequency (50-60 Hz) Leakage Current Enclosure source current, ground open

< 500 µA

Source current, patient leads, all outputs

Normal polarity, intact ground: < 10 µA Normal polarity, ground open: < 10 µA Reverse polarity, ground open: < 10 µA

Sink current at high line, all inputs

< 10 µA

High Frequency (RF) Leakage Current Bipolar RF leakage current

< 22 mA rms at 10 watts

Monopolar RF leakage current (additional tolerance)

< 150 mA rms

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) The Bovie® DERM 101/102 High Frequency Desiccator provides a high degree of protection against electric shock, particularly regarding allowable leakage currents. It is type BF equipment.

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 Bovie® equipment is placed on or beneath an activated Bovie® Medical High Frequency Desiccator, the Bovie® DERM 101/102 High Frequency Desiccator operates 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 Bovie® DERM 101/102 High Frequency Desiccator complies with the appropriate IEC 60601-1-2 and IEC 60601-2-2 specifications regarding electromagnetic compatibility.

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EMC COMPLIANCE Special precautions should be taken regarding the Bovie® DERM 101/102. 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. Understand that only the Accessories supplied with or ordered from Bovie Medical should be used with your device. The use of Accessories, transducers, and cables other than those specified, may result in increased Emissions or decreased Immunity of the Bovie® DERM 101/102. The Bovie® DERM 101/102 and its accessories are not suitable for interconnection with other equipment. Portable and mobile RF communications equipment can affect Medical Electrical Equipment. The Bovie® DERM 101/102 should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the Bovie® DERM 101/102 should be observed to verify normal operation in the configuration in which it will be used.

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Recommended separation distances between portable and mobile RF communications equipment and the Bovie® DERM 101/102. The Bovie® DERM 101/102 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Bovie® DERM 101/102 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Bovie® DERM 101/102 as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter

Separation distance according to frequency of transmitter in metres (m)

W

150 kHz to 80 MHz d = 1.2 P

80 MHz to 800 MHz d = 1.2 P

800 MHz to 2.5 GHz d = 2.3 P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Guidance and manufacturer’s declaration – electromagnetic emissions The Bovie® DERM 101/102 is intended for use in the electromagnetic environment listed below. The customer or the user of the Bovie® DERM 101/102 should assure that is is used in such an environment. Emissions test

Compliance

RF Emissions CISPR 11

Group 2

RF Emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

Service Guide • DERM 101/102

Electromagnetic environment - guidance

The Bovie® DERM 101/102 must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. The Bovie® DERM 101/102 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.

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Guidance and manufacturer’s declaration – electromagnetic immunity The Bovie® DERM 101/102 is intended for use in the electromagnetic environment listed below. The customer or the user of the Bovie® DERM 101/102 should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electrostatic discharge (ESD) IEC 61000-4-2

±6 kV contact ±8 kV air

±6 kV contact ±8 kV air

Electrical fast transient/burst IEC 61000-4-4

±2 kV for power supply lines ±1 kV for input/output lines

±2 kV for power supply lines

Surge IEC 61000-4-5

±1 kV differential mode ±2 kV common mode

±1 kV differential mode ±2 kV common

Not Applicable

Electromagnetic environment - guidance

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment.

<5 % Ut <5 % Ut (>95 % dip in Ut ) (>95 % dip in Ut ) for 0.5 cycle for 0.5 cycle

Mains power quality should be that of a typical commercial or hospital 40 % Ut 40 % Ut environment. If the user of the Voltage dips, short (60 % dip in Ut ) (60 % dip in Ut ) for Bovie® DERM 101/102 requires interruptions and voltage 5 cycles for 5 cycles continued variations on power supply operation during power mains 70 % Ut input lines 70 % Ut interruptions, it is recommended (30 % dip in Ut ) (30 % dip in Ut ) for IEC 61000-4-11 that the Bovie® DERM 101/102 be 25 cycles for 25 cycles powered from an uninterruptible power supply or a battery. <5 % Ut <5 % Ut (>95 % dip in Ut ) (>95 % dip in Ut ) for 5 sec for 5 sec Power frequency magnetic fields should be at levels characteristic 3 A/m of a typical location in a typical 3 A/m commercial or hospital environment. NOTE Ut is the a.c. mains voltage prior to application of the test level. Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

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Guidance and manufacturer’s declaration – electromagnetic immunity continued... Immunity test

Conducted RF IEC 61000-4-6

IEC 60601 test level

3 Vrms 150 kHz to 80 MHz

Compliance level

3 Vrms (V1)

Electromagnetic environment - guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Bovie® DERM 101/102™, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = [ 3.5] P 3

d = [ 3.5] P 3

80 MHz to 800 MHz

d = [7

3

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m (E1)

]

P

800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m) Field strengths from fixed RF transmitters, as determined by an electromegnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicated theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location which the Bovie® DERM 101/102 is used exceeds the applicable RF compliance level above, the Bovie® DERM 101/102 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Bovie® DERM 101/102.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.

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OUTPUT POWER CHARACTERISTICS Maximum Output for Bipolar and Monopolar Power readouts agree with actual power into rated load: - for Coagulation Mode - to within 20% or 0.1 watts, whichever is greater; - for Bipolar Mode - to within 20% for power settings >=1W; and to within 0.3 watts for power settings <1W Mode

Output Power

Output Frequency

Repetition Rate

Crest Factor @ Rated Load

Vp-p max

Coagulation

10 W @ 1000 Ω

550 kHz ± 44.9 kHz

19.5 kHz ± 10%

10.0 ± 20%

3.3 kV

Bipolar

10 W @ 200 Ω

550 kHz ± 44.9 kHz

19.5 kHz ± 10%

10.0 ± 20%

1.0 kV

* an indication of a waveform’s ability to coagulate bleeders without a cutting effect Figure 3–1 illustrates output power delivered to rated load for all available modes. Figure 3–2 illustrates power setting versus voltage for all modes. Figures 3–3 and 3–5 illustrates the maximum peak voltage available at a given power setting and output mode. Figures 3–4 and 3–6 are the output waveforms as viewed on an oscilloscope. Figure 3–1

Output power versus power setting for all modes

Figure 3–2

Power setting versus voltage (Vpeak) for all modes

Figure 3–3

Output Power versus Load • Bipolar 100% / 50%

Figure 3–4

Bipolar Mode Waveform

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Figure 3–5

Output Power versus Load • Monopolar 100% / 50%

Service Guide • DERM 101/102

Figure 3–6

Monopolar Mode Waveform

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THEORY OF OPERATION This section includes the following information: l Block diagram l Functional overview of key circuits l System logic l Bovie® DERM 101/102 control signal inputs and outputs.

Service Guide • DERM 101/102

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BLOCK DIAGRAM Figure 4-1 Functional block diagram of the Bovie® DERM 101/102 system

FUNCTIONAL OVERVIEW OF KEY CIRCUITS The following descriptions highlight the main circuits in the Bovie® DERM 101/102 High Frequency Desiccator.

High-voltage Power Supply +36VDC The unit incorporates a non-regulated high voltage power supply for the RF output power. The nominal DC voltage from the high voltage power supply is +36 VDC with tolerance between +33VDC and +37.5 VDC.

Low Voltage DC Supplies The unit incorporates two regulated low voltage levels to control generator operations. They are: +9 VDC, +5 VDC, +3.3 VDC, and +1.2VDC. • The +9 VDC circuit supplies power for the activation circuit, the audio circuit, the 7-segment display and Activation LED, and the RF drive circuit. This circuit turns on and off the power MOSFETS for the RF output power. • The +3.3 VDC and +1.2 VDC circuit supplies power for the logic system, and all temperature sensors.

ADC Voltage & Temperature Sensing The unit incorporates an analog-to digital converter (ADC) to continually monitor the power supply voltages for +9 VDC and +36 VDC . If this voltage is not within limits, the system displays Error Code E2 (36V) or Error Code E6 (9V) and disables the RF output. The ADC is also used by the system logic to monitor the internal temperature of the unit. If the temperature rises above 75° C, the system displays an error code and disables the RF output.

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Activation Sensing Circuit and Remote Power Up/Down The Activation Sensing Circuit is used by the system logic to detect both hand controlled activation and foot- controlled activation and up/down requests. This circuit is made up of a colpitts oscillator (operating at approximately 80 kHz) and a level detection circuit. In a non-activation status, the colpitts oscillator operates at its set operating frequency, and presents a sine wave to the up/down level detection circuit. The level detection circuit converts the sine wave into a square wave. Any Activation, or UP/DN command, will not occur as long as a square wave with certain duty cycle is present. When a resistance (approximately 45 Ω or less) is presented to the transformer’s secondary winding by a hand-control or foot-control, the sense transformer is essentially shorted. The “short” is felt on the transformer’s primarywinding causing the colpitts oscillator to temporarily shut down.When the oscillator shuts down, the sense signal becomes +3.3 VDC (logic “1”). This informs the system logic that a handswitch or footswitch activation request has been made. When a resistance (80Ω< 90 Ω <110Ω) is presented to the transformer’s secondary winding by the hand-control, the colpitts oscillator is not shut down, but changes it's amplitude and reducing it's duty cycle. The system logic can measure the duty cycle and recognizes this condition as a request for "Power UP". When a resistance (150Ω< 200 Ω < 330Ω) is presented to the transformer’s secondary winding by the hand-control, the system logic recognizes this condition as a request for "Power DOWN". NOTICE The activation circuit works with Bovie® handpiece A902.

If the square wave (from any of the request sense circuits) is having a duty cycle, higher than the maximum predefined value that is measured at the system logic when the unit is initially turned on, an error code is displayed, an alarm sounds, and the RF output is disabled.

Audio Control Circuit The audio circuit is used by the system logic to generate activation tones and alarm tones. Volume for the activation tones may be adjusted from the back panel of the unit. NOTICE Alarm volume cannot be adjusted up or down.

RF Amplifier Circuit The RF Amplifier Circuit generates the RF output energy that is delivered to the patient. It is a single-ended power amplifier incorporating two power MOSFETs, and a step-up transformer. The initial RF drive pulse is generated by the Digital PWM circuit and the system logic control block. When the RF drive pulse turns the power MOSFET “ON,” current flows from the high voltage supply through the output transformers, through the clamping diodes, and then through the MOSFET to high voltage ground The energy developed by the “ON” time is stored in an LC tank circuit. When the MOSFET are OFF the energy is delivered to the patient through the output capacitors. A longer “ON” time develops more energy in the LC tank circuit; therefore, more energy is delivered to the patient.

Controls and Indicators The Bovie ® DERM 101/102™ controls and indicators are listed below: • DISPLAYS Seven segment displays indicate the output power in watts. • ACTIVATION INDICATOR Blue LED indicates that the generator is activated. • POWER CONTROL KNOB These mechanical encoder adjust the output power for each mode.

Service Guide • Bovie® DERM 101/102

4-3

• POWER SWITCH A double pole single throw switch that snaps into the housing. This switch supplies the AC mains current to the generator.

Digital PWM Circuit The Digital Pulse Width Modulation (PWM) Circuit controls the output power of the unit. This digitally controlled signal is used by the system logic to provide a precise signal to the RF drive. The pulse width resolution is 12.5ns The pulse width is determined by power setting (generated by the user) on the front of the unit. When a power is selected, the system logic determines what the pulse width needs to be to deliver the requested output.

SYSTEM LOGIC The control logic uses a Field Programmable Gate Array as the “brain” of the Bovie® DERM 101/102 High Frequency Desiccator. This system interprets all of the inputs and delivers the correct corresponding outputs. Every operation of the unit is controlled from this system. A System Clock Circuit, composed of an oscillator, provides the basic operating frequency of 20 MHz. The Reset Circuit provides a single pulse at the time the Bovie® DERM 101/102 High Frequency Desiccator is turned on. This pulse resets Field Programmable Gate Array to ensure proper operation.

BOVIE® DERM 101/102 CONTROL SIGNAL INPUTS AND OUTPUTS The following table lists the important input and output signals. From a troubleshooting standpoint, the absence (and presence) of these signals will help you isolate problems. Signal Name

Description

VOL_CNTRL

This is the input signal to the control logic to change the audio volume.

BLUE_DIODE

These are signals from the system logic that illuminates the activation blue LED indicator.

ENCDR1_REQ ENCDR2_REQ

These are output signals from the encoder to control the power setting of the system.

CAL_MODE

Reserved for Calibration of the Activation Circuit.

CAL_BIT3- CAL_BIT0

Signals used to control the handle calibration fixture.

CAL_ENTER

Signal used to start the handle calibration fixture.

PC_SPI(CLK-CS-DIN-DOUT

RESERVED for DEBUG puposes

SPKR_DRV1 SPKR_DRV2

These are signals from the system logic that generates the activation tone and alarm tones. These signals are used by the audio circuit.

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RF_DRV

This is an output signal from the digital PWM circuit that controls the pulse width duration for the RF drive.

TEMP_SEN

This is an input signal from the Temperature Sense Circuit TS1 that informs the system logic if the internal

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temperature of the unit is above 75° C. The signal is measured by Analog-to Digital converter. VDDP

This is an input signal from the high voltage +36 VDC circuit that informs the system logic if a high voltage error has occurred. The power supply signals are measured by Analog-to Digital converter

9V

This is an input signal from the high voltage + 9 VDC circuit that informs the system logic if a voltage error has occurred. The power supply signals are measured by a Digital converter.

RQST_RECG

This is an input signal from the activation sense circuit. This signal is generated by a colpitts oscillator. When an activation request is made, this oscillator become a logic 1 (5 VDC) signal This is also an input signal for the UP or DOWN request command and is generated by a colpitts oscillator. The system measures the signal duty cycle and determines the type of the command request

Service Guide • Bovie® DERM 101/102

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OPERATING THE BOVIE® DERM 101/102 This section covers the following topics: ● Inspecting the generator and accessories ● Service personnel safety ● Installation and placement ● Functional (operational) checks ● Unit Operation.

Service Guide • DERM 101/102

5-1

INSPECTING THE GENERATOR AND ACCESSORIES Before each use of the Bovie® DERM 101/102, inspect the unit and all accessories to verify good working order: • Inspect for physical damage to the High Frequency Desiccator and its connections. • Verify that the appropriate accessories and adapters are present. • Inspect all cords and connectors for signs of wear, damage, and abrasion. • Verify that no error messages are displayed when the unit is turned on.

SERVICE PERSONNEL SAFETY WARNINGS Explosion Hazard – Do not install the generator in the presence of flammable anesthetics, gases, liquids, or objects. Fire Hazard – Do not place active accessories near or in contact with flammable materials (such as gauze or surgical drapes). Electrosurgical accessories that are activated or hot from use can cause a fire. Use a holster to hold electrosurgical accessories safely away from personnel and flammable materials. Fire Hazard – Do not use extension cords. Fire Hazard – For continued protection against fire hazard, replace fuses only with fuses of the same type and rating as the original fuse.

CAUTION 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. Unit is designed to be wall mounted or mounted on a mobile stand. Provide as much distance as possible between the electrosurgical generator and other electronic equipment (such as monitors). An activated electrosurgical generator may cause electrical interference with them. Do not turn the activation tone down to an inaudible level. The activation tone alerts the surgical team when an accessory is active. No modification of this equipment is allowed.

NOTICE Connect the power cord to a wall receptacle having the correct voltage. Otherwise, product damage may result.

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INSTALLATION AND PLACEMENT Mount the Bovie® DERM 101/102 on the wall or optional mobile stand using the standard mounting kit (see figure 5-1). Do not operate the unit in the horizontal position, as liquids may spill into unit. 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.

Figure 5-1 Installation and placement

FUNCTIONAL (OPERATIONAL) CHECKS Upon initial installation of the unit, perform the following checks. Refer to the figures in Controls and Indicators for the location of connectors and generator controls. WARNING At no time should you touch the active electrode or bipolar forceps. A serious burn could result.

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How to Set Up and Start the Bovie® DERM 101/102 Unit

Figure 5-2

Figure 5-3

Figure 5-4

DERM 101 1. Mount the Bovie® DERM 101/102 on the wall or optional mobile stand using the standard mounting kit (see figure 5-1). Do not operate the unit in the horizontal position, as liquids may spill into unit. 2. Plug the female end of the power cord into the base of the unit (see figures 5-2 and 5-3, letter A). 3. Plug the male end of the power cord into a grounded wall receptacle. 4. The monopolar output for the handpiece is on the lower left front of the unit (see figures 2 and 3, letter B). The handpiece plug is designed to fit in only one direction. Plug the connector from the handpiece into the receptacle on the bottom of the unit (see figures 5-2 and 5-3, letter B). The three button handpiece is designed to give the doctor complete fingertip control of the power output settings. 5. Slide the standard electrode into the handpiece until it is firmly seated (see figures 5-2 and 5-3, letter C). The handpiece will accept most standard 3/32" electrodes. 6. Slide the handpiece into the holder on the left side of the unit before powering on the unit. 7. Turn the unit power on utilizing the switch on the right side panel of the unit (see figures 5-2 and 5-3, letter D).

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8. Set the power output either by using the dial on the front of the unit (see figures 5-2 and 5-3, letter E) or on Bovie® DERM 101/102 unit only by the up and down buttons on the handpiece (see figures 5-2 and 5-3, letter J). When power level adjustment is being made by the handpiece an audible tone will sound to indicate that the power level has been changed. Depressing and holding the up or down buttons will cause the power settings to change more rapidly for quick adjustment of the output settings. Power output is displayed in “.1” watt increments from 0.1 to 10 watts. NOTICE: The output settings can not be adjusted when the unit is being activated.

9. To activate the unit, remove the handpiece from the holder. Place the handpiece in the desired position and depress the activation button (see figures 5-2 and 5-3, letter K). When the unit is activated, an audible tone is sounded and the blue active light will illuminate (see figures 5-2 and 5-3, letter F). 10. To use the optional grounding plate with cord (A802EU), insert the plug of the cord into the grounding plate output (see figures 5-2 and 5-3, letter G) and connect the other end into the grounding plate. The plate should be placed underneath the patient at a point where the entire plate is covered by bare skin. The use of conductive gel is recommended. 11. To use the optional bipolar cord (A827V), insert the plugs into the bipolar outputs (see figures 5-2 and 5-3, letter H). The cord is then plugged into the forceps. A sliding gate behind the monopolar and bipolar outputs prevents the user from using both simultaneously. 12. The optional footswitch (A803) is plugged into the footswitch output and placed on the floor (see figures 5-2 and 5-3, letter I). The footswitch can be used with monopolar procedures and must be used with bipolar procedures. 13. When the procedure is completed, turn the unit off utilizing the switch on the right side panel of the unit. 14. Return the handpiece to the holder on the right side of the unit and remove the electrode. The electrode should be disposed of after each procedure. If contamination has occurred to the handpiece, the handpiece should also be sterilized. 15. Adjustment of the audible tone is achieved by a switch located on the rear of the unit (see figure 5-4). Two tone choices are available, high and low. A small screwdriver will be necessary to make the adjustment.

Service Guide • DERM 101/102

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How to check the unit operation with a Footswitch 1. Connect a footswitch to the footswitch jack on the front of the unit. 2. Set the power setting to 0.1 watts. 3. Verify that the Activation LED illuminates blue, and that the system generates the Activation tone when you press the pedal on the footswitch. 4. Confirm that releasing the footswitch pedal returns the unit to an idle state.

How to Check the Monopolar Mode 1. Connect the monopolar handpiece A902 to the Monopolar receptacle. 2. Set the power setting to 0.1 watts. 3. Verify that the generator activates when the activation (blue) button on the handpiece is depressed.

UNIT OPERATION The Bovie ® DERM 101/102 High Frequency Desiccator produces radio frequency current which is useful for the removal and destruction of superficial cutaneous and mucosal lesions. This is done by performing desiccation and fulguration procedures. Electrosurgical desiccation occurs when the electrode is placed directly onto the surface of the lesion. Fulguration occurs when the electrode is held slightly above the lesion and an arc is delivered to the lesion. The unit also provides fast and efficient bleeding control by coagulation of capillaries and small blood vessels. For the majority of desiccation, fulguration, and coagulation procedures utilizing the standard handpiece in the monopolar output, the patient plate is optional. When used, the patient plate will intensify the coagulation properties of the unit and also lessen the opportunity for an electrosurgical burn. The optional footswitch adds versatility when using the standard handpiece in the monopolar output, as the footswitch allows you to activate the unit by either the handpiece or the footswitch. Bipolar outputs are available only in DERM 102™ for those physicians who prefer to utilize bipolar forceps to perform coagulation procedures. A footswitch is required when using the bipolar output. Procedures that are performed in sensitive areas may require an anesthetic. Flammable anesthetics should not be used. If you are unfamiliar with the operation of a low powered electrosurgery unit, it is advisable to practice on chicken or lean flank steak to visualize the effects at various output and power levels.

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MAINTENANCE This section includes the following information: ● Cleaning the unit ● Performing periodic inspection

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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 Bovie® DERM 101/102 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 and replace them with T0.4AH250V Slow Blow fuses. 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.

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Figure 6-1 Fuse

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TROUBLESHOOTING This section includes error code descriptions and actions to take to resolve them.

Service Guide • DERM 101/102

7-1

RECOMMENDED EQUIPMENT FOR TROUBLESHOOTING The following equipment enables you to troubleshoot and repair the Bovie® DERM 101/102. • Digital multimeter with leads • Electrosurgical analyzer or a true RMS voltmeter such as a Fluke 8920A • Wideband current transformer such as a Pearson 4100 • Non-inductive RF load resistors 200 ohms, 1000 ohms • Oscilloscope (dual channel) at 100 MHz • Oscilloscope probes, (2) 10X and 1000X • Bovie footswitch • Bovie handswitching pencil (single use or reusable) • Standard technician’s tool kit • Miscellaneous test leads and cables.

TROUBLESHOOTING THE BOVIE® DERM 101/102 If the generator is not functioning properly, use the information in this section to perform the following activities: • Identify and correct the malfunction. • If an error code was displayed, take the appropriate action(s) to correct the error condition.

Inspecting the Generator If the Bovie® DERM 101/102 malfunctions, check for obvious conditions that may have caused the problem. 1. Check the generator for visible signs of physical damage. 2. Verify that all accessory cords are properly connected. 3. Check the power cord. Replace the power cord if you find exposed wires, cracks, frayed insulation, or a damaged connector. 4. Remove the back panel and inspect all internal connections. 5. Verify that the fuses are firmly seated and are not blown. 6. You may need to replace the fuses if the generator fails to start up. Refer to Fuse Replacement in Section 6.

Inspecting the Receptacles Equipment required: • Footswitch • Bipolar cable (only for DERM 102™) • Monopolar instrument • Return electrode cable Procedure: 1.

Turn off the generator.

2.

Disconnect the power cord from the wall receptacle.

3.

Check the footswitch receptacle on the front of the unit for obvious signs of obstruction and damage.

4.

Check for a secure fit by inserting the footswitch connector into footswitch receptacle. If the footswitch receptacle is damaged, replace the footswitch connector.

5.

Check the Bipolar receptacle on the front of the unit for obstruction or damage (only for DERM 102™).

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6.

Insert a Bipolar cable into the bipolar receptacle on the front of the unit. Verify a secure fit. If the Bipolar receptacle is damaged, replace the Bipolar jacks.

7.

Check the Monopolar handpiece receptacle on the front of the unit for obstruction or damage.

8. Insert a Monopolar handpiece into the monopolar handpiece receptacle on the front of the unit. Verify a secure fit. If the Monopolar handpiece receptacle is damaged, replace the Monopolar jacks.

Inspecting Internal Components CAUTION The generator contains electrostatic-sensitive (ESS) components. When repairing the generator, work at a static-control workstation. Wear a grounding strap when handling electrostatic-sensitive components. Handle circuit boards by their nonconductive edges. Use an anti-static container for transport of electrostatic-sensitive components and circuit boards.

To inspect the internal components, follow this procedure: 1. Remove the four screws that secure the back panel to the unit. 2. Lift the back off the chassis. 3. Visually inspect and verify that all connectors are firmly seated. 4. Inspect the board for damaged components, wires, cracks and corrosion. 5. Reinstall the back panel by positioning the panel over the enclosure, and securing the four screws.

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UNDERSTANDING ERROR CODES AND AUDIO TONES The Bovie® DERM 101/102 includes automatic, perpetual self-diagnostics. If the diagnostics detect an error, the system displays an error code, sounds an audible tone, and deactivates the output power. Any errors detected will shut down the RF output power. NOTICE Internal firmware self-diagnostics continually monitor the unit’s operation to ensure proper and safe performance.

Most error codes result from faults in accessories attached to the unit. The following table lists the error codes, describes the error, and recommends actions to take to resolve the error. Error Code Description of Error

Recommended Action

E1

Internal Calibration Error

• Switch unit off and on again.

E2

DC Supply Over Voltage

• Switch unit off and on again.

Detection +36V

• Make sure unit is connected to correct power source for the unit.

E3

Pulse Width

• Switch unit off and on again.

E5

Temperature Error

• Switch unit off. Allow unit to cool. Switch unit on.

E6

DC Supply Over Voltage

• Switch unit off and on again.

Detection +9V

• Make sure unit is connected to correct power source for the unit.

Multiple Errors

• Switch unit off and on again.

E7

The following table lists Bovie® DERM 101/102 fault codes, their meaning and recommended actions to be taken to resolve the faults. The faults are resettable, i.e it is not necessary to switch unit off and on again to reset the fault condition. Fault Code Description of Fault F1

Recommended Action

Activation upon

• Check handpiece for activation.

power up

• Check footswitch for activation; once the activation is halted the unit will resolve the error. If the error persists the handpiece could be malfunctioning and may need to be replaced.

F2

Handpiece “Power-UP” upon

• Check handpiece for “Power-Up” command. Once the command is

power up

halted the unit will resolve the error. If the error persists the handpiece could be malfunctioning and may need to be replaced.

F3

Handpiece “Power-Down”

• Check handpiece for “Power-Down” command. Once the command is

upon power up

halted the unit will resolve the error. If the error persists the handpiece could be malfunctioning and may need to be replaced.

F4

F5

Power UP and Power

• Check handpiece for “Power-Up-Down” command. Once the command

Down are simultaneously

is halted the unit will resolve the error. If the error persists the handpiece

depressed

could be malfunctioning and may need to be replaced.

Duty Cycle Fault- unit is

• Do not exceed 30 second activation time for one activation request.

activated more than 30sec

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