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  • Page 2 USER’S GUIDE User ’s Guide • Bovie® IDS-400...
  • 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® IDS-400 only. Additional technical information is available in the Bovie® IDS-400 Service Guide.
  • Page 5: Table Of Contents

    TABLE OF CONTENTS Equipment Covered in this Manual................iii For Information Contact .....................iii Conventions Used in this Guide ..................iii Introducing the Bovie® IDS-400 ...................1-1 Indications For Use ......................1-2 Safety ..........................1-2 Contraindications.....................1-5 Key Features........................1-5 Components and Accessories..................1-7 Controls, Indicators, and Receptacles................2-1 Front Panel........................2-2 Symbols on the Front Panel..................2-3...
  • Page 6 Electromagnetic Compatibility (IEC 60601-1-2 and IEC 60601-2-2) ......A-4 Voltage Transients (Emergency Generator Mains Transfer) ........A-4 Output Characteristics ....................A-5 Maximum Output for Monopolar and Bipolar Modes ..........A-5 EMC Compliance......................A-5 Output Power Curves .....................A-9 Warranty ..........................B-1 User ’s Guide • Bovie® IDS-400...
  • Page 7 Figure A – 4 Output power versus impedance for Blend mode.........A-11 Figure A – 4 Output power versus impedance for Pinpoint mode........A-11 Figure A – 6 Output power vs impedance for Spray mode ..........A-12 Figure A – 7 Output power vs impedance for Bipolar mode ..........A-12 Bovie Medical Corporation...
  • Page 8: Introducing The Bovie® Ids-400

    Additional Accessories 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 • Bovie® IDS-400...
  • Page 9: Indications For Use

    To promote the safe use of the Bovie® IDS-400, 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 10 • 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 recom- mends the use of split return electrodes and Bovie generators with a contact quality monitoring system.
  • Page 11 Inadvertent contact with the patient may result in burns. Avoid HF output settings where maximum output voltage may exceed rated accessory voltage. Refer to the accessory’s voltage rating. Choose only accessories that will withstand each mode and power setting. Bovie Medical Corporation...
  • Page 12: Contraindications

    • Blend with 10 settings The Blend mode is a combination of cutting and hemostasis. The IDS-400 gives the surgeon freedom to adjust the desired level of hemostasis. A setting of 1 is minimal blend with maximum cutting effect. A setting of 10 is maximum hemostasis (blend) with minimal cutting effect.
  • Page 13 • Return electrode sensing and contact quality monitoring The IDS-400 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.
  • Page 14: Components And Accessories

    • User’s Guide • Service Guide Additional Accessories To avoid incompatibility and unsafe operation, we recommend using the following Bovie® accessories with the IDS-400: • ESREC - split pad with 2.8 M cable • ESRE - split pad adult return electrode •...
  • Page 15 Bovie Medical Corporation...
  • Page 16: Controls, Indicators, And Receptacles

    CONTROLS, INDICATORS, AND RECEPTACLES This section describes: ● The Front and Rear Panels ● Controls, Indicators, Receptacles, and Ports User ’s Guide • Bovie® IDS-400...
  • Page 17: Front Panel

    FRONT PANEL Figure 2 – 1 Layout of controls, indicators, and receptacles on the front panel Bovie Medical Corporation...
  • Page 18: Symbols On The Front Panel

    Symbols on the Front Panel Refer to the following table for descriptions of symbols found on the front panel of the IDS-400. SYMBOLS DESCRIPTION Cut Controls Cut Mode Blend Mode Coag Controls Pinpoint Mode Spray Mode Bipolar Controls Bipolar Mode...
  • Page 19: Preset Controls

    NOTICES: The IDS-400 incorporates 10 factory-set presets that are all set to zero and can be reset to your preferred settings. Set and Recall are disabled while the unit is activated.
  • Page 20: Cut And Blend Controls

    10 steps. Blend Mode Indicator Indicates when the Blend mode is selected. NOTICE: When selecting the Blend mode, the unit defaults to a setting of minimum blend (only the first bar is illuminated). User ’s Guide • Bovie® IDS-400...
  • Page 21: Coag Controls

    Illuminates when Coag mode is activated. Pinpoint Mode Indicator Indicates when the Pinpoint mode is selected. Pinpoint and Spray Mode Selector Toggles between Pinpoint mode and Spray mode. Spray Mode Indicator Indicates when the Spray mode is selected. Bovie Medical Corporation...
  • Page 22: Bipolar Controls

    Displays error code in the event Bipolar Power Control Buttons of an error. Increases or decreases the Bipolar power output in increments of 1 to 5 watts. Bipolar Activation Indicator Illuminates when Bipolar mode is activated. User ’s Guide • Bovie® IDS-400...
  • Page 23: Indicators

    Notices: the patient. Solid pad indicator only detects that a pad is connected to the unit. The unit does not moni- tor pad placement on the patient. Bovie Medical Corporation...
  • Page 24: Power Switch And Receptacles

    Power On/Off Switch Monopolar Footswitching Receptacle Bipolar Receptacle Turns the unit on or off. Accepts cables or adapters equipped Accepts standard cables for with standard active plugs. Connect bipolar handpieces. Connect footswitching accessories. bipolar accessories. User ’s Guide • Bovie® IDS-400...
  • Page 25: Rear Panel

    Do not dispose of this device in the unsorted municipal waste stream. Proper disposal required. Symbols on the Rear Panel Refer to the following table for descriptions of symbols found on the rear panel of the IDS-400. NOTICE: Please note that infected medical devices must be disposed of as medical/biohazard waste and...
  • Page 26: Getting Started

    GETTING STARTED This section includes the following information: ● Initial Inspection ● Installation ● Function Checks ● Performance Checks User’s Guide • Bovie® IDS-400...
  • Page 27: Initial Inspection

    INSTALLATION Place the Bovie® IDS-400 on any flat surface with a tilt angle not more than 10˚. 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.
  • Page 28: Confirming Modes

    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 • Bovie® IDS-400...
  • Page 29 Bovie Medical Corporation...
  • Page 30: Using The Bovie® Ids-400

    Activation Safety 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 • Bovie® IDS-400...
  • Page 31: Inspecting The Generator And Accessories

    INSPECTING THE GENERATOR AND ACCESSORIES Before each use of the Bovie® IDS-400, 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 accessories and adapters are present.
  • Page 32: Setting Up

    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. User ’s Guide • Bovie® IDS-400...
  • Page 33: Preparing For Monopolar Surgery

    PREPARING FOR MONOPOLAR SURGERY Monopolar surgery requires a return electrode. Applying the Return Electrode To maximize patient safety, Bovie 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.
  • Page 34: Setting And Recalling Memory Presets

    Memory The Memory feature allows the IDS-400 (unit) to display the last selected Preset when the generator is turned on. When activated by the handpiece or footswitch, the unit will operate in that particular mode and power setting.
  • Page 35: Setting Your Presets

    To recall a Preset, repeatedly press the Recall button to toggle through all of the presets. NOTICES: The IDS-400 incorporates 10 factory-set presets that are all set to zero and can be reset to your preferred settings. A small red dot blinking in the lower right corner of the Preset indicator display indicates that the unit is not presently set to a user-defined preset.
  • Page 36: Activating The Unit

    The Bovie IDS-400 will power up to the modes and settings displayed when the unit was last activated. For example, if you set Cut I mode at 50 watts and activate the unit, then turn the unit off, it will automatically return to Cut I mode at 50 watts when you turn it on again.
  • Page 37 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. Bovie Medical Corporation...
  • Page 38: Maintaining The Bovie® Ids-400

    MAINTAINING THE BOVIE® IDS-400 This section covers the following topics: ● Cleaning ● Periodic Inspection ● Fuse Replacement User’s Guide • Bovie® IDS-400...
  • Page 39: Cleaning

    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® IDS-400 for signs of wear or damage. In particular, look for any of the following problems: • Damage to the power cord •...
  • Page 40: Troubleshooting

    TROUBLESHOOTING This section includes Error Code Descriptions and actions to take to resolve them. User’s Guide • Bovie® IDS-400...
  • Page 41 The Bovie® IDS-400 includes automatic self-diagnostics. If the diagnostics detect an error, the system displays an error code, sounds an audible tone, and deactivates the unit output power. Most error codes result from faults in accessories attached to the unit. The following table lists the error codes, describes the errors, and recommends actions to take to resolve the errors.
  • Page 42: 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® IDS-400...
  • Page 43: 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 44 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 45 Bovie Medical Corporation...
  • Page 46: 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® IDS-400...
  • Page 47: Performance Characteristics

    Generator should fit on all standard Carts for monopolar generators. 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 48: 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® IDS-400...
  • Page 49: High Frequency (Rf) Leakage Current

    The Bovie IDS-400 complies with the appropriate IEC 60601-1-2 and IEC 60601-2-2 specifications regarding electromagnetic compatibility. Voltage Transients (Emergency Generator Mains Transfer) The Bovie IDS-400 operates in a safe manner when the transfer is made between line AC and an emergency generator voltage source. Bovie Medical Corporation...
  • Page 50: Output Characteristics

    Portable and mobile RF communications equipment can affect Medical Electrical Equipment. The IDS-400 should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the IDS-400 should be observed to verify normal operation in the configuration in which it will be used.
  • Page 51 Guidance and manufacturer’s declaration – electromagnetic emissions The IDS-400 is intended for use in the electromagnetic environment listed below. The customer or the user of the IDS-400 should assure that is is used in such an environment.
  • Page 52 Guidance and manufacturer’s declaration – electromagnetic immunity The IDS-400 is intended for use in the electromagnetic environment listed below. The customer or the user of the IDS-400 should assure that is is used in such an environment. IEC 60601 Immunity test...
  • Page 53 If the measured field strength in the location which the IDS-400 is used exceeds the applicable RF compliance level above, the IDS-400 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the IDS-400.
  • Page 54: Output Power Curves

    . Figure A – 1 Output power versus voltage for all modes Figure A – 2 Output power versus impedance for Cut I mode User’s Guide • Bovie® IDS-400...
  • Page 55 Figure A – 3 Output power versus impedance for Cut II mode Figure A – 4 Output power versus impedance for Blend Min mode A-10 Bovie Medical Corporation...
  • Page 56 Figure A – 5 Output power vs impedance for Blend Max mode Figure A – 6 Output power vs impedance for Pinpoint mode A-11 User’s Guide • Bovie® IDS-400...
  • Page 57 Figure A – 7 Output power vs impedance for Spray mode Figure A – 8 Output power vs impedance for Bipolar mode A-12 Bovie Medical Corporation...
  • Page 58 Figure A – 9 Power setting versus output power for Cut I mode Figure A – 10 Power setting versus output power for Cut II mode A-13 User’s Guide • Bovie® IDS-400...
  • Page 59 Figure A – 11 Power setting versus output power for Blend (Min and Max) mode Figure A – 12 Power setting versus output power for Pinpoint mode A-14 Bovie Medical Corporation...
  • Page 60 Figure A – 13 Power setting versus output power for Spray mode Figure A – 14 Power setting versus output power for Bipolar mode A-15 User’s Guide • Bovie® IDS-400...
  • Page 61 A-16 Bovie Medical Corporation...
  • Page 62: Warranty

    Bovie’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’s factory in a way so as, in Bovie’s judgment, to affect its stability or reliability, or which has been subjected to misuse, neglect, or accident.
  • Page 63 Pinellas, State of Florida, USA. Bovie, 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.
  • Page 64 2014-02-11...

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