Instruction Manual. (English-English)

Transcription

1 Instruction Manual (English-English)

2 Copyright Information 2014 Cynosure, Inc. Cynosure, Ellman and RadioLase are registered trademarks of Cynosure, Inc. Caution Federal law restricts this device to sale by or on the order of a Physician

3 CONTENTS I. INTRODUCTION Page 4 II. SAFETY Page 4 III. TECHNICAL INFORMATION Page 7 IV. DESCRIPTION OF CONTROL ELEMENTS Page 7 V. PREPARATION FOR USE Page 12 VI. SURGICAL DESCRIPTION AND USE Page 12 VII. POWER OUTPUT CHARACTERISTICS Page 14 VIII. TECHNICAL SPECIFICATIONS Page 17

4 I. INTRODUCTION 1.0 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. 1.1 INTENDED USE The intended use for the Radiolase 3 Generator is: Monopolar Cutting: Skin and Mucosal Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, Skin Tags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection Monopolar Blended Cutting & Coagulation: Skin Tags, Papilloma, Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repair, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures Monopolar Hemostasis: Control of Bleeding, Epilation, Telangiectasia Bipolar Hemostasis: Pinpoint Hemostasis in any field (Wet or Dry). Note: The Radiolase 3 Generator is not indicated for non-ablative treatment of wrinkles. Furthermore, the Radiolase 3 Generator is neither designed to provide the required power levels, nor withstand the demands of lengthy non-ablative wrinkle treatment procedures. The Radiolase 3 Generator will overheat and possibly fail if used for non-ablative treatment of wrinkles. Such failures will not be covered by warranty. II. SAFETY Improper use of this, or any high frequency surgical instrument, can result in a patient injury. Read and become familiar with all instructions and directions before using this product. 2.0 WARNINGS High frequency surgical equipment should be used only by persons having adequate training and familiarity with high frequency surgical equipment and related techniques. A thorough understanding of the use of high frequency surgical equipment is essential to avoid shock and burn hazards to both patient and medical personnel and damage to the device or other medical equipment. Consult medical literature relative to related techniques, complications, and hazards prior to use of high frequency surgical equipment Never increase the power settings without first checking both the active electrode and the Neutral Pad Non-conductive Corneal Eye Shields (Plastic) must be used for any radiofrequency surgical procedure involving the eyelid and the immediate surrounding areas Use only with Ellman accessories including Ellman handpieces, Neutral Pads, cables, and electrodes. 4

5 2.1 PRECAUTIONS General Interference caused by the Generator could adversely affect the operation of other electronic equipment Electrical shock hazard. Do not remove cover. Refer to authorized personnel for service Generator may present a hazard to patients with pacemakers. Consult qualified medical personnel If higher than normal power settings are required, examine all cables, handpieces and the Neutral Pad for damage and confirm that cables are not wrapped around metal objects or touching the floor. In the event that higher power is still required, replace the Neutral Pads and handpieces Do not cut or modify any cables The patient should not come into contact with metal parts which are earthed or which have appreciable capacitance to earth. The use of antistatic sheeting is recommended for this purpose Physician to patient skin to skin contact should be avoided. Use of insulating gloves is recommended When the Generator is used simultaneously with physiological monitoring equipment on the same patient, the monitoring electrodes should be placed as far as possible from the surgical electrodes. Needle monitoring electrodes are not recommended. Monitoring systems incorporating high-frequency current-limiting devices are recommended The cables to the 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 segregated from the patient The output power selected should be as low as possible for the intended purpose Apparent low output or failure of the surgical equipment to function correctly at the normal operating settings may indicate faulty application of the Neutral Pad or poor contact in its connection Before each use inspect the accessories, electrode cables and probes for possible physical damage Do not obstruct air circulation vents For surgical procedures where the high frequency current could flow through parts of the body having a relatively small cross-sectional area, the use of bipolar techniques may be desirable to avoid unwanted coagulation Similar to all energy sources, by-products such as tissue smoke plume and aerosols, create a health concern about their carcinogenic and infectious potential. Appropriate protective measures including effective smoke evacuation should always be utilized Neutral Pad The use and proper placement of the Neutral Pad is essential to the safe and effective use of this device in order to prevent burns from the Neutral Pad. The Neutral Pad should be reliably attached with its entire area attached to the patient s body as close as possible to the operating field. Direct skin contact is necessary for a conductive Neutral Pad. Direct skin contact is not necessary for a capacitive Neutral Pad The Neutral Pad should not be placed on the patients head or other areas where it does not make complete skin contact If patient is repositioned during treatment, check and verify the Neutral Pad is still making complete contact to the patient. Check the Neutral Pad for signs of heating during procedures. 5

6 2.1.3 Flammable Environment Some materials, for example cotton, wool, and gauze when saturated with oxygen may be ignited by sparks produced in normal use of the equipment Do not use the Generator in the presence of flammable anesthetics or other flammable gases, flammable liquids, or flammable objects Do not use this device in oxygen enriched atmospheres or in the presence of nitrous oxide (N20) Use only non-flammable agents for cleaning Flammable agents used as solvents for removing adhesives should be allowed to evaporate before powering on the Generator. Any flammable fluid pooled under the patient or in the body depressions should be mopped up prior to using the Generator. Attention should be called to the danger of ignition of endogenous gases. NOTE: To ensure safe and reliable operation, the Radiolase 3 Generator unit and relevant accessories should be checked for wear and tear before operation. A maintenance contract with the manufacturer or one of its authorized service agents is recommended after the warranty period. 3.0 SUPPLIER S INFORMATION Cynosure, Inc. dba Ellman 400 Karin Lane Hicksville, New York U.S.A. (516) (800) III. TECHNICAL INFORMATION Supplier will make the following available upon request; circuit diagrams, component parts list, description, calibration instructions or other information necessary to assist technical personnel. ATTENTION: Alcohol must never be used to clean and disinfect the front panel. 3.2 CLEANING, DISINFECTING AND STERILIZING THE UNIT AND ACCESSORIES Use only nonflammable and nonexplosive agents. No moisture or detergents should enter the unit Handpiece and Electrodes. Always clean and disinfect the electrodes prior to sterilization. Disinfect and sterilize handpieces and electrodes according to the directions supplied with them. All autoclavable products should be routinely inspected for any wear, breaks, or deterioration of the insulation, and should be discarded and replaced if any of these occurrences exist The footswitch is a waterproof unit; it can be cleaned with regular detergent. 6

7 4.0 INTERFACE ACCESORIES IV. DESCRIPTION OF CONTROL ELEMENTS 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 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 IEC Neutral Pad The IEC Neutral Pad must be used with the RF Generator during activation. To use, insert the molded plug of the Neutral Pad into the RF Generator as shown in Figure Power Cord The power cord connects RF Generator to power supply. 7

8 4.1 REAR PANEL CONTROL ELEMENTS Figure 4.1 Rear Panel 3 2 Cynosure, Inc. dba Ellman HF RADIO SURGICAL GENERATOR MODEL P/N Operating Frequency 4 MHz POWER OUTPUT MONOPOLAR BIPOLAR 500 OHM LOAD 200 OHM LOAD CUT 50 WATTS CUT/COAG 50 WATTS HEMO 35 WATTS 35 WATTS RATED DUTY CYCLE 20 SEC ON, 30 SEC OFF SUPPLY RATINGS at 50-60Hz VAC 0.80A 220 VAC 0.90A 120 VAC 1.40A 100 VAC 1.70A FUSE (2) VAC : T1.25A, 250V 100/120 VAC : T2.0A, 250V POWER ENTRY VOLUME FOOT SWITCH Power Cord 2 Power Socket 3 Line Fuses 4 Audio Volume Control 5 Footswitch Receptacle 6 7 Footswitch Pedal Speaker 8

9 4.2 FRONT PANEL CONTROL ELEMENTS Figure 4.2 Front Panel 6a 6 4a 9 5a a 7 8a 8 92 NEUTRAL FINGERSWITCH/HANDPIECE BIPOLAR HANDPIECE! ON / OFF NEUTRAL PAD MONOPOLAR FINGERSWITCH HANDPIECE BIPOLAR HANDPIECE OR CABLE 1 Power Switch: 1 = ON 0 = OFF 9

10 2 Power On Indicator: 3 Neutral Pad Receptacle: 4 Bipolar Cord Receptacle: 5 Fingerswitch/Handpiece Receptacle: 6 Yellow Light (Monopolar Cut Energized) Indicator: The indicator illuminates the Monopolar when Cut function is selected and has been selected and energized. 7 Yellow Light (Monopolar Cut/Coag Energized) Indicator: The indicator illuminates when the Monopolar Cut/Coag function is selected and has been energized. 8 Blue Light (Monopolar Hemo Energized) Indicator: The indicator illuminates when Monopolar Hemo function is selected and has been energized. 9 Monopolar Mode Select Knob 10 Monopolar Power Intensity Setting Knob: The selected output power will be delivered to the patient for true output power. See figures in section Blue Light (Bipolar Hemo Energized) Indicator: The indicator illuminates when Bipolar Hemo function is selected and has been energized. 12 Bipolar Power Intensity Setting Knob: The selected power will be delivered to the patient for true output power. See figures in section SYMBOL DEFINITIONS 10

11 4.3.1 Type BF defibrillator protection! Refer to manual Protective earth connection Neutral electrode floating at high frequency Fingerswitch control Footswitch control Neutral Pad Non-Ionization radiation Equipotential Symbol 11

12 V. PREPARATION FOR USE 5.0 PREPARATION FOR USE On the Generator check to make sure that the power switch is in the OFF position Connect the power cord to a 3-wire ground AC power receptacle Insert the Neutral Pad plug into the receptacle on the front panel marked Neutral The Neutral Pad should be reliably attached as per Section Plug the handpiece into the appropriate receptacle on front panel Make sure that the electrode is seated fully so that no conductive shaft is exposed. 5.1 WAVEFORM SELECTION Reference Section 7 Power output characteristics for more details about waveforms CUT - For micro-smooth cutting CUT/COAG - For cutting with coagulation HEMO - For pure Hemostasis-Coagulation to control most forms of bleeding. 5.2 SMOKE HAZARD By-products of high frequency surgical procedures are an occupational exposure hazard. Standards based policies and procedures must be developed in all practice settings to protect personnel. VI. SURGICAL DESCRIPTION AND USE 6.0 LEARNING TO USE RADIOSURGERY Before making contact with the tissue, the power intensity must be selected and the foot pedal or fingerswitch must be activated. During the actual cutting, it is important to use a smooth uninterrupted motion with light, even pressure. The movement should not be too slow. If it is, the build-up of lateral heat in the tissue may cause charring, followed by necrosis and sloughing (see Preoperative Cutting Practice Section 6.1). When performing a second or third cut in the same surgical site, allow approximately ten seconds for the tissue to cool between applications of the electrode to the site. Unlike a steel scalpel or standard electrosurgery, Radiosurgery does not use manually applied pressure to cut. Therefore, a light, smooth, continuous, and brush-like stroke should be developed. Tissue damage will occur if heat is allowed to accumulate to the point where excessive dehydration occurs. The spread of lateral heat in tissue depends upon various factors as indicated in the following formula: Time x Power Lateral Heat+? Frequency Additionally the electrode type and selected waveform impact the thermal build up. A. Time of Electrode Contact B. Power Level C. Frequency Tissue provides lower resistance to higher frequencies, reducing thermal build up. D. Electrode Type A broader electrode tip requires more power and creates greater thermal spread. E. Nature of the Waveform - See Section 5.1 for details 12

13 6.1 PRE-OPERATIVE CUTTING PRACTICE Prepare the Generator for operations as described in Section 5- PREPARATION FOR USE, then follow the steps below. A. 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. B. Place the meat on a Neutral Pad. C. Insert the electrode of choice (Empire, Loop, Diamond, Vari-Tip, etc.) into the handpiece. D. Select "MONOPOLAR CUT". E. Set output power intensity to 5. F. Depress the MONOPOLAR Footswitch pedal or Fingerswitch button. G. Using a smooth, brush-like motion, make several incisions of various lengths and depths. If you notice that the electrode will not cut, cuts only with pulling and dragging, or if tissue shreds adhere to the electrode while cutting, then increase the power gradually until a smooth cut occurs. H. If the setting is too high then you will notice sparking and discoloration along the electrode path. Reduce power and repeat the procedure as outlined above. I. Repeat the above procedure until such a point when no discoloration occurs and there is no visible sparking. The Radiosurgical tip should not encounter resistance. The cut should be smooth without sparking and without any drag. 6.2 PRE-OPERATIVE COAGULATION PRACTICE Intermittent gentle contact with the tissue is performed until bleeding stops. Effective coagulation is achieved when the treated area appears on the meat as blanched spot. Feather-light touching of the ball electrode is recommended to coagulate bleeders efficiently. A. 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. B. Place the meat on a Neutral Pad. C. Insert a ball electrode into the Handpiece. D. Select MONOPOLAR HEMO. E. Set the output power intensity to 5. F. Position the ball electrode in light contact with the beef. G. Depress the MONOPOLAR Footswitch pedal or the Fingerswitch button. H. Adjust power setting for desired results. Bleeding should be stopped by some form of direct manually applied pressure. When bleeding has momentarily stopped, final sealing of the vessels can be accomplished by brief application of the partially rectified modulated waveform. Bipolar can also be used for coagulation. 13

14 VII. POWER OUTPUT CHARACTERISTICS Figure 7.0 Typical Nominal Plot Power Output vs. Dial Setting Monopolar: 500 Ohm load Bipolar: 200 Ohm Load Figure 7.1 Typical Nominal Plot Monopolar Cut Power Output vs. Resistive Load 14

15 Figure 7.2 Typical Nominal Plot Monopolar Cut/Coag Power Output vs. Resistive Load Figure 7.3 Typical Nominal Plot Monopolar Hemo Power Output vs. Resistive Load 15

16 Figure 7.4 Typical Nominal Plot Bipolar Hemo Power Output vs. Resistive Load Figure 7.5 Typical Nominal Plot Voltage Output vs. Dial Setting (Open Circuit) 16

17 VIII. TECHNICAL SPECIFICATIONS 8.0 OUTPUT CHARACTERISTICS Mode/ Output Nominal Power Output Power Output Activation Character Waveform Output Power vs. Setting vs. Load Resistance Cut 4.0 MHz 50W See Figure 7.0 See Figure 7.1 via footswitch or 500 Ω fingerswitch Cut/Coag 4.0 MHz with 50W See Figure 7.0 See Figure 7.2 via footswitch or fully 500 Ω fingerswitch envelope Hemo 4.0 MHz with 35W See Figure 7.0 See Figure 7.3 via footswitch or partially 500 Ω fingerswitch envelope Bipolar 4.0 MHz with 35W See Figure 7.0 See Figure 7.4 via footswitch Hemo partially 200 Ω envelope RF Power-out is within 20% of nominal above (when the dial setting is greater than 1). RF Power-out is stable within 10% within 10 seconds after activation. RF output frequency is within 10% of nominal. NOTE: The open-circuit output peak-to-peak voltage for all modes is approximately 1200 Volts. 8.1 PREVENTIVE INSPECTION AND MAINTENANCE Regular preventive inspection should be carried out to prevent reduced safety of the unit due to aging, wear and tear, etc. The cable and electrode must be checked before each use. The Generator must be inspected for technical safety at least once a year. The required technical safety inspection is detailed in the Maintenance Manual. The manufacturer assumes no responsibility for improper changes or repairs carried out on the unit or its accessories by unauthorized persons, and the warranty of the unit expires immediately. 17

18 8.2 SAFETY FEATURES Standard Compliance IEC IEC IEC Electrical Safety Electric Shock: Defibrillator Protection Class I Type BF Neutral Pad Earthed at HF Defined duty cycle protection 20 sec. ON / 30 sec. OFF Ingress of water Ordinary equipment. 8.3 INPUT CHARACTERISTICS Nominal line voltage 100V, 120V / 220V, 240V ~ + 10% Line frequency 60 Hz./50 Hz Input current at max output power 0.80A; 230/240VAC 0.90A; 220VAC 1.40A; 120VAC 1.70A; 100VAC Rating of fuses in the main supply T 1.25A, 250V, 240V, 220V power T 2.0A, 250V, 120V, 100VAC 8.4 SIZE AND WEIGHT W x H x D 10 x 4.5 x Weight 10 lbs. 8.5 OPERATING CONDITIONS Ambient Temperature: +10 C C Relative Humidity: 30% - 75% 8.6 TRANSPORTATION & STORAGE CONDITIONS Ambient Temperature: -10 C C Relative Humidity: 10% - 95% Atmospheric Pressure: 500 hpa hpa 18

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20 Cynosure, Inc. dba Ellman, 400 Karin Lane, Hicksville, N.Y U.S.A. Tel: Fax: DIM REV E 8 December 2015