USER’S GUIDE User’s Guide • DERM 101/102 1
TABLE OF CONTENTS Introduction..................................................................................................................................................3 Operating Principle ...................................................................................................................................3 Safety...............................................................................................................................................................3 Introduction..
INTRODUCTION Thank you for purchasing the Bovie® DERM 101/102. Please visually check the unit to ensure that damage did not occur during shipment and that all standard items are included. If there are any discrepancies, please contact Bovie® at +1-727-384-2323. For the latest user information and technical bulletins, visit www.boviemed.com. OPERATING PRINCIPLE RF energy is generated and passed through an interconnecting cable to an accessory, where the energy is delivered to coagulate and desiccate tissue.
WARNINGS: Electric Shock Hazard - Connect the generator power cord to a properly grounded receptacle. Do not use power plug adapters. Electric Shock Hazard - Always turn off and unplug the generator before cleaning. Fire Hazard - Do not use extension cords. No modification of this equipment is allowed. Patient Safety - Use the generator following the directions described in the Setup Procedures. Otherwise, inaccurate power outputs may result.
as close to the operating field as possible. Refer to NE instructions for use. The cables to surgical electrodes should be positioned in such a way that contact with the patient or other leads is avoided. Temporarily unused active electrodes should be stored so that they are isolated from the patient. Do not wrap the accessory cords or return electrode cords around metal objects. This may induce currents that could lead to shocks, fires, or injury to the patient or surgical team.
CAUTIONS: When not using active accessories, place them in a holster or in a clean, dry, non-conductive, and highly visible area not in contact with the patient. Inadvertent contact with the patient may result in burns. Avoid HF output settings where maximum output voltage may exceed rated accessory voltage. Refer to the accessory’s voltage rating. To avoid incompatibility and unsafe operation, use suitable cables, accessories, active and neutral electrodes, including values for the highest allowed H.F.
Site of Use • Soft tissue (skin, muscle) Patient Population – * Patient should not be user. • Age: Infant to geriatric • Weight: > 2.5kg • Patient State: Alert, relaxed, may be sedated, having had local anesthetic applied. Intended User Profile • Education – Trained physician, physician’s assistant, nurse, nurse practitioner.
Figure 1 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 Figure 2 receptacle on the bottom of the unit (see figures 2 and 3, letter B). The three button handpiece is designed to give the doctor complete fingertip control of the power output settings. 5.
Figure 3 8. Set the power output either by using the dial on the front of the unit (see figures 2 and 3, letter E) or on Bovie® DERM 101/102 unit only by the up and down buttons on the handpiece (see figures 2 and 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.
12. The optional footswitch (A803) is plugged into the footswitch output and placed on the floor (see figures 2 and 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.
Catalog # A802EU Description Reusable Grounding Pad A837 Wall Mount Kit A910 Disposable handpiece sheath, non-sterile 110 VAC Hospital-grade power cord 09-064-001 IP-55-229 User’s/Service Manual CD Quantity Models Recommended All Models 1 pcs All models 2 pcs All models 1 pcs For 110VAC models only (220VAC cord to be shipped only with special order units) All models 1 pcs NOTICES: *A902 Handpiece shall be used with the DERM 101/102 Only.
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. Recommended separation distances between portable and mobile RF communications equipment and the Bovie® DERM 101/102.
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 Electrostatic discharge (ESD) IEC ±6 kV contact 61000-4-2 ±8 kV air Compliance level ±6 kV contact ±8 kV air Electromagnetic environment guidance Floors should be wood, concrete or ceramic tile.
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.
TROUBLESHOOTING The Bovie® DERM 101/102 has been designed and manufactured with the utmost safety in mind. The unit is equipped to automatically detect a malfunction. The following table list error codes, their meaning and recommended actions to be taken 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 Detection +36V • Switch unit off and on again.
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.
GRAPHS Figure 5 illustrates output power delivered to rated load for all available modes at selected power settings. Figure 6 illustrates power settings versus Vpeak voltage for all available modes. Figures 7 and 9 illustrate output power load curves. Figures 8 and 10 are the output waveforms as viewed on an oscilloscope.
DESCRIPTION OF SYMBOLS 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.
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.
20 Bovie Medical Corporation
2014-06-10