Bovie Icon Gi User Manual
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Bovie Icon Gi User Manual

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Summary of Contents for Bovie Icon Gi

  • Page 2 USER’S GUIDE User ’s Guide • Bovie Icon Gi™...
  • Page 3 Bovie Medical Corporation...

  • Page 4: Equipment Covered In This Manual

    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 Bovie Icon Gi™ only. Additional technical information is available in the Bovie Icon Gi™ Service Guide.

  • Page 5: Terminology

    TERMINOLOGY The following terminology is used throughout this guide to describe specialized features and functionality of the Bovie Icon Gi™. Touch Screen – Touch screen located on the unit’s front panel. This area is used to enter and view user selections such as modes, power setting, and presets.
  • Page 6 It can also be used for bipolar cutting instruments with direct contact to tissue. Gentle Bipolar – The Gentle Bipolar mode does not require a patient return pad. This coagulation mode significantly reduces charring and sticking of the electrode. User ’s Guide • Bovie Icon Gi™...

  • Page 7: Table Of Contents

    Checking Monopolar Mode (with BV-1253BGI footswitch) ........3-3 Checking Monopolar Mode (with handswitch) ............3-4 Checking Bipolar Mode (with BV-1253BGI footswitch) ...........3-4 In-Service ........................3-4 Performance Checks.......................3-4 Using the Icon Gi ........................4-1 Inspecting the Unit and Accessories ................4-2 Setup Safety........................4-2 Initial Set Up........................4-3 Selecting Unit Properties....................4-4 Select Presets ......................4-6...
  • Page 8 Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2) ......A-4 Voltage Transients (Emergency Generator Mains Transfer) ........A-4 EMC Compliance......................A-4 Output Characteristics ....................A-8 Maximum Output for Monopolar and Bipolar Modes..........A-8 Output Power Curves .....................A-9 Warranty ..........................B-1 User ’s Guide • Bovie Icon Gi™...
  • Page 9 Figure A – 7 Output power vs impedance for Gentle Bipolar mode........A-12 LIST OF TABLES Table 2 – 1 Table of symbols found on the front panel ............2-3 Table 2 – 2 Table of symbols found on the back panel............2-4 viii Bovie Medical Corporation...

  • Page 10: Introducing The Icon Gi

    CAUTIONS: Read all warnings, cautions, and instructions provided with this unit 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 • Bovie Icon Gi™...

  • Page 11: Key Features

    The system also continually monitors the contact quality between the patient and the split pad. This feature is designed to minimize patient burns at the pad site. A split pad must be used with the Icon Gi™. An alarm will sound if a solid pad is detected.

  • Page 12: Components And Accessories

    • Icon Gi™ USB Memory Stick • User’s Guide ADDITIONAL ACCESSORIES To avoid incompatibility and unsafe operation, we recommend using the following Bovie accessories with the Icon Gi™: • ESREC - split pad with 2.8 M cable • BV-1253BGI - footswitch •...

  • Page 13: Safety

    To promote the safe use of the Icon Gi™, this section presents the warnings and cautions that appear throughout this user’s guide. It is important that you read, understand, and follow the instructions in these warnings and cautions so that you can operate this equipment with maximum safety.
  • Page 14 • In addition, place patient return electrodes according to the manufacturer’s instructions. Potential for alternate site burns increases if the return electrode is compromised. Bovie Medical recommends the use of split return electrodes and Bovie units with a contact quality monitoring system.
  • Page 15 If required by local codes, connect the unit to the hospital equalization connector with an equipotential cable. Do not clean the unit with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch the panels or damage the unit. Bovie Medical Corporation...

  • Page 16: Touch Screen And Receptacles

    This section describes: ● The Front and Rear Panels ● Touch Screen Controls, Indicators, Receptacles, and Symbology Descriptions NOTICE: Refer to Section 4 of this guide for instructions on using the Icon Gi™ ESU. User ’s Guide • Bovie Icon Gi™...

  • Page 17: Front Panel

    Used to transfer data to and Receptacle USB Types B and A Accepts hospital grade Refer to Section 5 for from the Icon Gi. . Used to transfer data to and fuse replacement power cord. from the Icon Gi .

  • Page 18: Symbols

    Symbols Table 2 – 1 Refer to the following table for descriptions of symbols found on the front of the Icon Gi™. SYMBOLS DESCRIPTION Cut/Blend Controls Pure Cut Mode Blend Mode 1 Blend Mode 2 Blend Mode 3 Safe Cut Mode...
  • Page 19 Symbols Table 2 – 2 Refer to the following table for descriptions of symbols found on the back of the Icon Gi™. SYMBOLS DESCRIPTION Equipotential Ground Stud Non-ionizing Radiation Fuse Enclosed Danger - Explosion Risk If Used With Flammable Anesthetics.

  • Page 20: Main Screen

    Selects the unit’s setup controls (i.e, brightness, volume, language). NOTICES: Activation is only available from the Main Screen and shows the requested powers and modes. The Physician and Procedure Presets are also displayed in this screen. User ’s Guide • Bovie Icon Gi™...

  • Page 21: Cut/Blend And Coag/Bipolar Keypad Screens

    The number in the upper right corner indicates the highest power available for that mode. Clear Buttons Used to reset selections so user can re-enter desired settings. Enter Buttons Your settings will be saved and you are returned to the previous screen. Bovie Medical Corporation...

  • Page 22: Unit Properties Screen

    See Figure 2-9. NOTICE: English is the default language for the Icon Gi. Detailed directions for changing the language are provided in Section 4 of this manual. See following page for additional Unit Properties screens. User ’s Guide • Bovie Icon Gi™...

  • Page 23: Additional Screens

    Use this button to download data from the unit to the memory stick. NOTICE: BV-USBGI-256 - Only use Icon Gi USB Memory Stick with this unit. Figure 2 – 8 RF Mode example Figure 2 – 9 View unit properties from this pop-up screen. RF Modes...

  • Page 24: Select Or Edit Preset Screens

    These pop-up screens allow the user to enter or edit information corresponding to the Select Physician screen or the Select Procedure screen. Touching Clear will reset information. Use the Backspace button or arrow buttons to delete characters or replace characters. User ’s Guide • Bovie Icon Gi™...
  • Page 25 2-10 Bovie Medical Corporation...

  • Page 26: Getting Started

    GETTING STARTED This section includes the following information: ● ● Initial Inspection ● ● Installation ● ● Function Checks ● ● In-Service ● ● Performance Checks User ’s Guide • Bovie Icon Gi™...

  • Page 27: Initial Inspection

    INSTALLATION Place the Icon Gi on any flat surface with a tilt angle not more than 10˚ or on a Icon Gi™ mobile stand. Do not block rear fan vents. Ensure that air flows freely on all sides of the unit.

  • Page 28: Improper Pad Placement

    A split pad is not necessary when using the Bipolar modes. Visual and Audible Indicators Visual Unit activation can easily be monitored by observing the Bovie Logo located on the front of the unit. Yellow Cut/Blend/Safe mode is activated. Blue Coagulation/Bipolar mode is activated.

  • Page 29: Checking Monopolar Mode (With Handswitch)

    A split pad is not necessary when using the Bipolar modes. IN-SERVICE An initial orientation may be conducted with your Bovie representative. All of the set-up steps and function checks will be covered with your In-Service. The features and functionality of your unit will also be covered at that time.

  • Page 30: Using The Icon Gi

    ● Inspecting the Unit and Accessories ● Setup Safety ● Initial Set Up ● Selecting Unit Properties ● Physician and Procedure Presets ● Preparing for Surgery ● Activating the Unit ● Activation Safety User ’s Guide • Bovie Icon Gi™...

  • Page 31: Inspecting The Unit And Accessories

    INSPECTING THE UNIT AND ACCESSORIES Before each use of the Icon Gi, verify that the unit and all accessories are in good working order: • Inspect for damage to the unit and all its connections. • Verify that the appropriate accessories and adapters are present.

  • Page 32: Initial Set Up

    During normal operation, the top, sides, and rear panel are warm when you use the generator continuously for extended periods of time. 3. Connect the Icon Gi power cable or a hospital grade power cable to the AC power cable receptacle on the back of the unit, then to a properly grounded wall outlet.

  • Page 33: Selecting Unit Properties

    Language (default English) NOTICE: English is the default language for the Icon Gi. If language is changed from default, the button on the Unit Properties screen will change to display the user-set language. To change the language from the Unit Properties screen: 1.

  • Page 34: Figure 4 - 3 Data Exchange Screen

    Bovie Memory Stick, touch the DBase I/O button to enter the DBase Exchange pop- up screen. 1. Plug your Bovie Memory Stick into the USB port located on the front of the unit. 2. Touch the desired exchange. A new pop-up screen appears with additional instructions.

  • Page 35: Select Presets

    PHYSICIAN AND PROCEDURE PRESETS The Icon Gi incorporates user-defined memory preset settings for easy recall of frequently used settings. Each physician (user) can enter their name and procedure mode and wattage settings. The physicians and procedures are then listed and can be quickly accessed and activated.

  • Page 36: Edit Presets

    9. Touch the Cut/Blend or Coag/Blend section of the window. The selected Set Mode & Power pop-up screen will appear. 10. Touch the desired mode, enter power setting and touch Enter. The Physician Preferences screen appears. User ’s Guide • Bovie Icon Gi™...

  • Page 37: Delete Presets

    If adjustments are made, the Procedure field will be blank, allowing the user to activate this setting or proceed with Editing the last listed Procedure Preset with the new settings. Figure 4 – 9 Max. wattage available Bovie Medical Corporation...

  • Page 38: Preparing For Surgery

    Selecting the CUT/BLEND Settings The Icon Gi allows users to select from two Cut and three blended cut Modes and power settings. From the Main Screen, the power setting can be adjusted up and down using the Up/Down arrows.

  • Page 39: Selecting The Coag/Bipolar Settings

    To exit without saving the settings touch the exit button. Selecting the COAG/BIPOLAR Settings The Icon Gi allows users to select from two Coag Modes and two Bipolar Modes and power settings. From the Main Screen, the power setting can be adjusted up and down using the Up/Down arrows.

  • Page 40: Activation Safety

    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. Danger: Fire / Explosion Hazard - Do not use the Icon Gi in the presence of flammable anes- thetics.
  • Page 41 4-12 Bovie Medical Corporation...

  • Page 42: Maintaining The Icon Gi

    MAINTAINING THE ICON GI™ This section covers the following topics: ● Cleaning ● Periodic Inspection ● Fuse Replacement User ’s Guide • Icon Gi...

  • Page 43: Cleaning

    Do not allow fluids to enter the chassis. Do not sterilize the unit. PERIODIC INSPECTION Every six months, visually inspect the Icon Gi for signs of wear or damage. In particular, look for any of the following problems: • Damage to the power cord •...

  • Page 44: Troubleshooting

    TROUBLESHOOTING This section includes the following information: ● ● Fault Code Messages ● ● Fatal Error Messages ● ● Touch Screen Recalibration User ’s Guide • Bovie Icon Gi™...

  • Page 45: System Fault Code Messages

    The Icon Gi includes automatic self-diagnostics. If the diagnostics detects a fault or error, the system displays an error message in the Warning pop-up screen, sounds an audible tone, and deactivates the unit’s output power. Most fault codes result from faults in accessories attached to the unit.

  • Page 46: System Fatal Error Messages

    If a fatal error message is displayed, follow the instructions in the display, “Unit Requires Qualified Service - Power off unit and and call 727-384-2323”. All system faults and errors are recorded and stored for future diagnostic reference. User ’s Guide • Bovie Icon Gi™...

  • Page 47: Recalibration Of The Touch Screen

    RECALIBRATION OF THE TOUCH SCREEN Your Icon Gi is calibrated before it is packaged and shipped. If the Touch Screen is not responding properly to screen taps, recalibrate Touch Screen. 1. From the Main screen touch the Setup button. The Unit Properties screen appears.

  • Page 48: Repair Policy And Procedures

    REPAIR POLICY AND PROCEDURES Refer to this section for information on: ● ● Responsibility of the Manufacturer ● ● Returning the Generator for Service User ’s Guide • Bovie Icon Gi™...

  • Page 49: Responsibility Of The Manufacturer

    Medical Corporation, first obtain a Returned Goods Authorization Number. Then, clean the Unit and package securely to ensure proper protection of the unit. So as to aid in the processing of the unit, please be sure to include a reference to the Bovie Return Goods Authorization Number on the outside of the box and ship directly to Bovie Medical Corporation.

  • Page 50: Step 3 - Ship The Unit

    Bovie understands that this may not always be possible. If necessary, contact Customer Service for the proper packaging to ship the unit. Please be sure to include a reference of the Bovie Return Goods Authorization Number on the outside of the box/container.
  • Page 51 Bovie Medical Corporation...

  • Page 52: 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 • Bovie Icon Gi™...

  • Page 53: Performance Characteristics

    Transport and Storage The device should be stored and used in a room temperature of approximately 77 F/25 Ambient temperature range -40˚ to +70˚ C Relative humidity 10% to 100%, including condensation Atmospheric pressure 50kPa to 106kPa Bovie Medical Corporation...

  • Page 54: Audio Volume

    Normal polarity, intact ground: < 10 µA Source current, patient leads, all outputs Normal polarity, ground open: < 10 µA Reverse polarity, ground open: < 10 µA Sink current at high line, all inputs < 10 µA User ’s Guide • Bovie Icon Gi™...

  • Page 55: High Frequency (Rf) Leakage Current

    Portable and mobile RF communications equipment can affect Medical Electrical Equipment. The Icon Gi™ should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the Icon Gi™ should be observed to verify normal operation in the configuration in which it will be used.
  • Page 56 Guidance and manufacturer’s declaration – electromagnetic emissions The Icon Gi™ is intended for use in the electromagnetic environment listed below. The customer or the user of the Icon Gi™ should assure that is is used in such an environment.
  • Page 57 Guidance and manufacturer’s declaration – electromagnetic immunity The Icon Gi™ is intended for use in the electromagnetic environment listed below. The customer or the user of the Icon Gi™ should assure that is is used in such an environment. IEC 60601...
  • Page 58 If the measured field strength in the location which the Icon Gi™ is used exceeds the applicable RF compliance level above, the Icon Gi™ should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Icon Gi™.

  • Page 59: Output Characteristics

    30 kHz 420 V 1.4 ± 20% Bipolar 80 W @ 100 Ω 492 kHz 30 kHz 1000 V 3.3 ± 20% Gentle Bipolar 50 W @ 25 Ω 492 kHz 30 kHz 220 V 1.4 ± 20% Bovie Medical Corporation...

  • Page 60: Output Power Curves

    Figures A–1 through A–7 illustrate specific output power delivered to a range of load resistances for each mode. Figure A – 1 Output power vs impedance for Cut (Pure) mode Figure A – 2 Output power vs impedance for Blend modes User ’s Guide • Bovie Icon Gi™...

  • Page 61: Figure A - 3 Output Power Versus Impedance For Safe Cut Mode

    Figure A – 3 Output power versus impedance for Safe Cut mode Figure A – 4 Output power versus impedance for Pinpoint mode A-10 Bovie Medical Corporation...

  • Page 62: Figure A - 5 Output Power Vs Impedance For Gentle Coag Mode

    Figure A – 5 Output power vs impedance for Gentle Coag mode Figure A – 6 Output power vs impedance for Bipolar mode User ’s Guide • Bovie Icon Gi™ A-11...

  • Page 63: Figure A - 7 Output Power Vs Impedance For Gentle Bipolar Mode

    Figure A – 7 Output power vs impedance for Gentle Bipolar mode A-12 Bovie Medical Corporation...

  • Page 64: Warranty

    This warranty does not apply to any product, or part thereof, which has been repaired or altered outside Bovie Medical Corporation’s factory in a way so as, in Bovie Medical Corporation’s judgment, to affect its stability or reliability, or which has been subjected to misuse, neglect, or accident.
  • Page 65 Notwithstanding any other provision herein or in any other document or communication, Bovie Medical Corporation’s liability with respect to this agreement and products sold hereunder shall be limited to the aggregate purchase price for the goods sold by Bovie Medical Corporation to the customer.
  • Page 66 2013-03-19...

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