CONTENTS INTRODUCTION Page 4 SAFETY Page 4 III. TECHNICAL INFORMATION Page 7 DESCRIPTION OF CONTROL ELEMENTS Page 7 PREPARATION FOR USE Page 12 SURGICAL DESCRIPTION AND USE Page 12 VII. POWER OUTPUT CHARACTERISTICS Page 14 VIII. TECHNICAL SPECIFICATIONS Page 17...
I. INTRODUCTION INTRODUCTION TO RADIOSURGERY ® Radiosurgery with the Radiolase 3 High Frequency Radio surgical Generator (Generator) is an ® ® excellent method of cutting and coagulating soft tissue. With four waveforms (3 monopolar and 1 bipolar) and a wide selection of electrode tips, the user can easily configure the system for a wide array of applications.
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PRECAUTIONS 2.1.1 General 2.1.1.1 Interference caused by the Generator could adversely affect the operation of other electronic equipment. 2.1.1.2 Electrical shock hazard. Do not remove cover. Refer to authorized personnel for service. 2.1.1.3 Generator may present a hazard to patients with pacemakers. Consult qualified medical personnel.
2.1.3 Flammable Environment 2.1.3.1 Some materials, for example cotton, wool, and gauze when saturated with oxygen may be ignited by sparks produced in normal use of the equipment. 2.1.3.2 Do not use the Generator in the presence of flammable anesthetics or other flammable gases, flammable liquids, or flammable objects.
IV. DESCRIPTION OF CONTROL ELEMENTS INTERFACE ACCESORIES 4.0.1 Two Pedal Footswitch Footswitch for CUT (yellow) and COAG (blue) modes is supplied. The footswitch may be used with any handpiece compatible with the RF Generator. 4.0.2 Handpieces A variety of handpieces are available. When using a fingerswitch handpiece, the depressed button will activate monopolar energy in the mode and power level selected on the front panel.
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REAR PANEL CONTROL ELEMENTS Figure 4.1 Rear Panel Cynosure, Inc. dba Ellman HF RADIO SURGICAL GENERATOR MODEL Operating Frequency 4 MHz FOOT POWER OUTPUT SWITCH MONOPOLAR BIPOLAR 500 OHM LOAD 200 OHM LOAD 0413 50 WATTS VOLUME CUT/COAG 50 WATTS HEMO 35 WATTS 35 WATTS...
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FRONT PANEL CONTROL ELEMENTS Figure 4.2 Front Panel FINGERSWITCH/HANDPIECE BIPOLAR HANDPIECE NEUTRAL ON / OFF NEUTRAL MONOPOLAR BIPOLAR FINGERSWITCH HANDPIECE HANDPIECE OR CABLE Power Switch: 1 = ON 0 = OFF...
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Power On Indicator: Neutral Pad Receptacle: Bipolar Cord Receptacle: Fingerswitch/Handpiece Receptacle: Yellow Light (Monopolar Cut Energized) Indicator: The indicator illuminates the Monopolar when Cut function is selected and has been selected and energized. Yellow Light (Monopolar Cut/Coag Energized) Indicator: The indicator illuminates when the Monopolar Cut/Coag function is selected and has been energized.
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4.3.1 Type BF defibrillator protection 4.3.2 Refer to manual 4.3.3 Protective earth connection 4.3.4 Neutral electrode floating at high frequency 4.3.5 Fingerswitch control 4.3.6 Footswitch control 4.3.7 Neutral Pad 4.3.8 Non-Ionization radiation 4.3.9 Equipotential Symbol...
V. PREPARATION FOR USE PREPARATION FOR USE 5.0.1 On the Generator check to make sure that the power switch is in the OFF position. 5.0.2 Connect the power cord to a 3-wire ground AC power receptacle. 5.0.3 Insert the Neutral Pad plug into the receptacle on the front panel marked “Neutral”. 5.0.4 The Neutral Pad should be reliably attached as per Section 2.1.2.
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PRE-OPERATIVE CUTTING PRACTICE Prepare the Generator for operations as described in Section 5- PREPARATION FOR USE, then follow the steps below. Select a piece of fresh, lean beef containing very little fat. Allow meat to reach room temperature. Note: Do not use veal because it does not change color when cut with an electrode. Place the meat on a Neutral Pad.
VIII. TECHNICAL SPECIFICATIONS OUTPUT CHARACTERISTICS Mode/ Output Nominal Power Output Power Output Activation Character Waveform Output Power vs. Setting vs. Load Resistance 4.0 MHz See Figure 7.0 See Figure 7.1 via footswitch or sinusoid @ 500 Ω fingerswitch Cut/Coag 4.0 MHz with See Figure 7.0 See Figure 7.2 via footswitch or...
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SAFETY FEATURES 8.2.1 Standard Compliance IEC60601-1 IEC60601-1-2 IEC60601-2-2 8.2.2 Electrical Safety Electric Shock: Class I Defibrillator Protection Type BF 8.2.3 Neutral Pad Earthed at HF 8.2.9 Defined duty cycle protection 20 sec. ON / 30 sec. OFF 8.2.10 Ingress of water Ordinary equipment.
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Cynosure, Inc. dba Ellman, 400 Karin Lane, Hicksville, N.Y. 11801 U.S.A. Tel: 800 835-5355 • 516 594-3333 • Fax: 516 279-4483 • www.ellman.com DIM-50-54 REV E 8 December 2015...
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