Hyfrecator 2000
Contents
1. 0 5 10 15 20 25 30 35 40 Power Display Setting Figure 12 H yirecator200 an Figure 13 Load Regulation Curves 24 40 35 30 Output Power Output Power Output Power 25 20 15 10 5 0 25 20 15 10 35 30 25 20 15 10 HI Mode Load Regulation 35 W 18 W 500 1000 Ohms LO Mode Load Regulation 1500 2000 2500 3000 500 1000 Ohms BI Mode Load Regulation 1500 2000 2500 3000 1500 2000 Ohms 500 1000 2500 30002. e Nabothian Cysts Puncture these infected glands and cysts with a sharp needle point then desiccate Skene s Glands Insert a sharp point into the abscess or cyst then desiccate using a strong current The wound closes by granulation 14 INN 2 210 2000 Dental and Oral Surgery e Apicoectomy To prepare for an apicoectomy insert a fine desiccating needle electrode Cat No 705A slightly beyond the apex of the tooth then apply the desiccating current to the infected area The resulting coagulation reduces capillary bleeding and minimizes the spread of infection during later root resection Buccal Gingival Caries Soft infected gingival tissue responds to desiccating currents Cysts Mucous Small cysts of the mouth respond to epilation An application of the desiccating current for a few seconds will boil out the mucous fluid and destroy the cyst lining Results are excellent with minimal scarring Dentin Desensitization Fulguration desensitizes hypersensitive exposed dentin Spray the area with a topical anesthetic before the first treatment then fulgurate with a weak current Only two treatments are usually required Frenectomy Intense fulguration of the superfluous tissue under local anesthesia reduces abnormal labial frenum e Hemostasis To control bleeding after exodontia desiccation or fulguration with a small ball electrode Cat No 727 can be most effective Gingivectomy The removal of gingival tissue such
3. Handle or the defective footswitch If the error code is 7 the HYFRECATOR 2000 detected that either the activation button or the Power Up Down Switching handle was pressed or the footswitch was activated while the output power was being changed Do not attempt to activate the unit during power changes If the error code cannot be cleared the unit must be returned for service Refer to Section 13 Repair and Return Policy for instructions Section 13 Repair and Return Policy HYFRECATOR 2000 units and any standard or optional accessories should not be returned to the manufacturer for warranty or non warranty repair without prior authorization A Return Authorization RA number will be issued by CONMED Customer Service department upon request To receive an RA number please call 800 552 0138 extension 5274 NOTE Any merchandise returned to CONMED without a Return Authorization number will not be accepted by the receiving department and will be returned to the sender The CONMED Warranty and Return Policy for the HYFRECATOR 2000 supersedes all other warranties either expressed or implied and shall be governed and executed under the laws for the State of New York U S A Section 14 Environmental Protection The shipping container and packing material should be retained in the event the unit must be returned for factory service At the end of the equipment s life it should be disposed of in accordance with your lo
4. a mild soap and water solution Rinse thoroughly with water and allow to dry Do not immerse in fluids Place the handpiece in a peel pack breather bag and on an open tray Mixture EO HCFC 124 90 10 Concentration 550mg L minimum to 650mg L maximum Temperature 130 degrees F 55 degrees C not to exceed 145 degrees F 63 degrees C Vacuum 25 inches Hg minimum to 27 inches Hg maximum Pressure 12 psi maximum Time 2 hours Humidity 30 RH minimum to 80 RH maximum Aeration 8 hrs 140 degrees E 60 degrees C OR 12 hrs 120 degrees E 50 degrees C For further information or instructions please refer to the AORN Recommended Practices Committee s Proposed Recommended Practices for Sterilization in the Practice Setting published in AORN Journal July 1994 Vol 60 No 1 pages 109 119 and or ANSI AAMI ST35 1991 Good Hospital Practice Handling and Biological Decontamination of Reusable Medical Devices Hyirecator2000 rs 7 800 6 Footswitching Handpiece The reusable autoclavable footswitching handpiece is steam sterilizable see instructions below This accessory requires the use of a footswitch Cat No 7 900 4 to activate the HYFRECATOR 2000 Also note that if a footswitch is utilized a sterile disposable non switching handpiece Cat No 137657 and a reusable adapter Cat No 670 3 can be used with the HYFRECATOR 2000 To steam sterilize footswitching handpiece and electrodes e Place acc
5. as the exposure of the gingival margin the preparation for taking hydrocolloid impressions and papillectomies and the elimination of gum flaps responds to both electrodesiccation and fulguration Root Canal Sterilization The dental electrode Cat No 705A can sterilize the pulp chamber after first removing the debris Use one second bursts of fulguration and gradually move the electrode deeper into the chamber and root canal Ophthalmology Chalazion Meibomian Cysts To treat these cysts first anesthetize the area Next incise and evacuate the cysts Entropion Treat each nodule by inserting a very fine needle point electrode Cat No 714 Use a low powered desiccating current Treat only a small portion at each session Xanthelasma These cholesterol deposits respond effectively to light desiccation or light fulguration Several treatments are preferable to avoid any scarring Burn Entropion Light fulguration is recommended Spastic Entropion Following surgical incision and desiccation to separate it from the orbicularis oculi muscle desiccate the muscle lightly until it is a light brownish green color Suture and dress the wound with antibiotic ointment Hyirecator2000 Is Otolaryngology Adenoid Hypertrophied Remnants Coagulate small areas under local anesthesia and repeat the process until the hypertrophied areas are completely destroyed Epistaxis Electrodesiccation is very effective for hemostasis An
6. cure rate with excellent cosmoses Flat Warts Verrucae Plana Flat warts respond well to light electrofulguration MALIGNANT LESIONS If malignancy is suspected take a biopsy before treatment by electrosurgery for histopathologic examination The most common skin cancers are basal and squamous cell carcinomas Appropriately selected ones may be treated easily quickly and effectively with curettage and electrofulguration You usually need to repeat the procedure once or twice at the same sitting to achieve a high cure rate The tumors you wish to treat generally should be less than two centimeters in diameter occurring on a sun exposed site face arms upper back lower legs and not involving a body fold such as the alar groove or inner canthus of the eye When lesions are chosen appropriately as noted above very acceptable cure rates for electrosurgery can be achieved In addition electrosurgery has the advantage of being easy to learn simple to perform and cost effective Cosmeses is quite acceptable and in many cases may be preferable to the cosmetic results of excisional surgery or radiotherapy Basal Cell Carcinoma Obtain a shave biopsy before electrosurgery After initial tumor delineation with a curette fulguration is performed and followed by thorough removal of the necrotic debris with additional curettage Curettage and fulguration is typically repeated once or twice 13 Hyirecator2000 rs Bowen s Disease
7. the Handswitched Pencil with a footswitch The unconnected switch connector can arc to nearby objects or personnel and cause a burn Connect the generator electrical cord to a properly grounded receptacle Do not use extension cords or two wire adapters Do not connect wet accessories to the generator The Hyfrecator 2000 must be mounted vertically to reduce the possibility of spilled liquids entering the chassis and adversely affecting the safety of the unit Anesthesia As in other types of surgery the amount and type of anesthetic required for procedures depends upon the site of the operation and the tolerance of the patient Small lesions can sometimes be removed without anesthetics when they are not in sensitive areas Do not use explosive or flammable anesthetics due to the presence of the spark created by the HYFRECATOR 2000 Similarly when the site is cleaned with alcohol or other flammable cleansing agents dry the surface thoroughly before proceeding Monoterminal Shock In all electrical devices where a current is emitted from the instrument the current must have a return path The return path for monoterminal applications is through the patient s body to the ground and back to the instrument In this mode if any portion of the patient s body comes in contact with a grounded metal object such as a chair or metal rail the current will take the path of least resistance and a slight shock may be felt To minimize the possibi
8. 2000 rs e Application The two types of coagulation have different effects on tissue In the first case the dispersive patient plate deeply draws the current into the tissue The current efficiently flows through the patient back to the HYFRECATOR 2000 producing heavy dehydration at the electrode site Conversely the use of bipolar forceps during bipolar coagulation produces the least tissue damage with the current remaining on the surface as it flows from one tine to the other e Healing same as desiccation Post Operative Care same as desiccation Section 8 Applications Dermatology BENIGN LESIONS The HYFRECATOR 2000 can destroy a variety of benign skin lesions With its wide range of power settings the HYFRECATOR 2000 treats even the most delicate facial lesions as well as the thickest scaling lesions of the trunk Some of the clinical applications include e Acrochordon skin tag Electrodesiccation or fulguration quickly destroys these lesions The remaining char is removed with a gauze pad or curette e Actinic Keratoses These pre malignant lesions respond well to light electrofulguration Since these lesions occur on exposed surfaces a cosmetic result is essential Using a low power setting will help you control the destruction and ensure a satisfactory cosmetic result e Adenoma Sebaceum Treat each papule with desiccation using a low power setting e Angiokeratoma Superficial desiccation is generally suff
9. Operators Manual Manual Hyfrecato r2000 E L E T RO SURGICAL UNIT Serving the Physician Since 1937 O 1998 CONMED Corporation 310 Broad Street Utica New York 13501 For Technical Services or Return Authorization Phone 303 699 7600 1 800 552 0138 For Customer Services or to order parts phone 1 800 448 6506 or contact your CONMED Representative European Authorized Representative MDSS GmbH Burckhardtstr 1 D 30163 Hannover Germany The revision level of this manual is specified by the highest revision letter found on either the inside front cover or enclosed errata pages if any Manual Number 7 900 OM Rev A Unit Serial Number Section OMPNAMNMBEWNHe Figure OCANA TB WH FE Hyfrecator2000 Table of Contents Title Page INtrOd CHON ai e A ASA aa 1 Inspection sisien crire da a AAA 1 Safety Precautions and Warnings o oooooccorcroco eee 1 Operating Controls and Indicators o o ooooooooooconor eee 4 Operation of Your Instrument oo oooooooro eee 7 Suggestions for First Time Operation 0 0 000000 0c eee 7 Terminology for Systems Configuration s s s 0 00 cece eee 8 Terminology for Procedural Configuration 2 0 0 00 e eee eee 10 Applications 2000 eee Corea dete A AA SUE Ee Ee ee eee es 12 MAITIEEM ANCE s edie aed dye aust as aids la dl dada a Abd di 17 Optional Accessories seo ee oe be ew gw Mee ee a ee ee BORA 18 Warranty A ee wad ad ete elgg se
10. Squamous Cell Carcinoma in Situ These lesions respond to the same techniques for basal cell carcinomas Since these lesions may extend further laterally than they clinically appear anesthesia should extend one to two centimeters beyond the visible lesions Bowenoid Papulosis Occurring on the genitals these papules respond to electrofulguration e Squamous Cell Carcinoma The same techniques are again employed as with basal cell carcinoma You should only treat lesions arising in sun damaged areas Squamous cell carcinomas arising in non sun exposed skin and in mucous membranes are more aggressive biologically Plastic Surgery Many surgeons use the HYFRECATOR 2000 for hemostasis in plastic and reconstructive surgery It saves time and produces minimal tissue reaction compared to other methods Coagulation occurs by touching each bleeding point with an electrodesiccating current Because blood will dissipate the energy a sponge should be used prior to application Gynecology Vaginal Cysts Treat these cysts by first excising an oval strip and emptying the contents then use a strong desiccating current to cauterize the interior Gartner cysts extending near the vault and alongside the cervix respond to this method Condylomata of the Vulva You can effectively destroy these warts as you would destroy the various types of warts on the surface of the body see Venereal Warts under Dermatology and Urology Cervical Polyps Cervic
11. ailable Ask your Authorized CONMED Distributor for details 12 HYFRECATOR 2000 TRAINING VIDEO Common Dermatologic Procedures Cat No 7 900 21 A 15 minute physician training tape covering basic dermatologic procedure such as the treatment of moles warts skin tags seborrheic keratoses telangiectasis and skin cancers 13 HYFRECATOR 2000 SERVICE MANUAL Cat No 7 900 SM Contains parts lists schematics maintenance instructions calibration procedures theory of operation and troubleshooting guide It is designed to be used with this manual Section 11 Warranty As manufacturer of the CONMED HYFRECATORO 2000 and other high quality medical equipment CONMED warrants all of its products to be free from defects in material and workmanship under normal operation and use The warranty period for the CONMED HYERECATORO 2000 is twelve 12 months to the products original owner NOTE The warranty card must be returned by the original owner to CONMED within ten 10 days of receipt of the invoice A ninety 90 day warranty is provided for standard and optional accessories The ninety 90 day warranty includes the power up down switching handle and cord There is no warranty on disposable single use items The warranty is limited to the repair or replacement at the manufacturer s discretion of any HYFRECATOR 2000 or part thereof that is returned to the manufacturer within the specified warranty period and which after examina
12. al polyps up to two centimeters in diameter respond to desiccation of the base without the need for a local anesthetic If shallow a fulgurating spark may blanch them thoroughly Polyps extending into the cervical canal may require more than one treatment Remember that endocervical and intrauterine polyps may be present Dilation and curettage of the uterine cavity under general anesthesia may be indicated As with all such lesions preliminary biopsy is advisable Pruritus Vulvae By fulgurating the entire surface using a strong current excellent results can be achieved Take care to prevent urethral stenosis Urethral Tumors The majority of urethral tumors are benign and respond readily to desiccation However treatment should be thorough to avoid recurrence e Cervical Erosion Many cervical erosions are asymptomatic and require no treatment However if the erosions produce symptoms such as increased discharge or pain you should treat them effectively with desiccation fulguration or coagulation Typically this is done without the need for a local anesthetic Cervicitis A strong desiccating current effectively destroys the entire infected mucosa although more than one treatment is usually necessary Bartholin s Cysts or Abscesses Aspiration alone may cure the condition if this fails incise the cyst or abscess evacuate its contents and coagulate the cyst wall using a fulgurating spark Recurrent cysts respond to marsupialization
13. cal regulations Component materials are Thermoplastic enclosure and stainless steel mounting plate Thermoset printed wiring boards containing miscellaneous electronic components Power transformer made of steel and copper e Mains cord and pencil accessory made of thermoplastic and copper e Accessory electrodes are stainless steel and thermoplastic Electrodes contaminated with biological waste should be disposed of as biologically hazardous material Shipping container and packing material are a combination of cardboard and plastic film n INN 2 210 2000 PARAMETER Primary Power Requirements Model 7 900 100 Model 7 900 115 Model 7 900 220 Model 7 900 230 Dimension and Weight Depth Width Height Weight Functional Characteristics Max Power Max Voltage Setting Watts Vpp Section 15 Specifications CHARACTERISTICS 100V 10 50 60 Hz 0 9 A 115V 10 50 60 Hz 0 8 A 220V 10 50 60 Hz 0 5 A 230 240V 10 50 60 Hz 0 5 A 4 inches 102 mm 8 75 inches 222 mm 7 5 inches 190 mm 6 pounds 2 7 kg Rated Load Repetition Frequency Ohms KHz 35 35 00 00 Power Accuracy at Rated Load LO and BI 0 to 10 W Greater of 90 mW or 10 of setting 10 to maximum setting 10 of setting HI Greater of 1 W or 10 of setting NOTE Instrumentation errors can be great enough to exceed these limits For best results the same instruments should be used for calibration as well as c
14. contact while the unit is activated or a burn could result at the last point of contact Place the dispersive plate under a well vascularized muscle mass that is thoroughly clean and dry Clean and shave site as necessary to provide adequate electrical connection Avoid Figure 4 Monoterminal with placement over scar tissue bony prominences or other areas Dispersive Plate Configuration where pressure points on small areas might develop Bipolar For bipolar configurations the current flow is similar to monoterminal techniques except the electricity never spreads deeply into the tissue Instead forceps or other highly specialized electrodes keep the current flow on the surface travelling from one tine of the forceps to the other see Figure 5 Bipolar techniques produce coagulation and are recommended for procedures requiring more efficient coagulation or hemostasis NOTE Bipolar forcep procedures require the use of a footswitch Figure 5 Bipolar Configuration E Hyirecator2000 rs Section 7 Terminology for Procedural Configuration Desiccation Desiccation comes from the Latin word desiccate meaning to dry It is a monoterminal without a dispersive plate technique The electrode either touches or is inserted into the tissue The current evaporates the cellular fluids blanching the area treated see Figure 6 Typically the depth of blanching is greater with desiccation than with fulguration Fi
15. ctric shock particularly in regard to the allowable leakage current and the reliability of the Protective Earth connection Explosion risk if used with flammable anesthetics This equipment intentionally supplies non ionizing RF energy for physiological effect Neutral electrode referenced to earth Patient Plate Connection Lo Monopolar Coagulation Handswitch Connection Hi Monopolar Coagulation Footswitch Connection Bipolar Coagulation Wall Mount Screw Location 3 INIA Drip proof Enclosure pr RE Power Adjustment 22 INN 20 Section 17 Index of Reference Material 1 Clover G B and Peutherer J E Herpes Simplex Virus Dispersal by Hyfrecator Electrodes British Journal of Dermatology Dec 1987 Vol 177 p 627 2 Sheretz E E et al Transfer of Hepatitis B Virus by Contaminated Needle Electrodes after Electrodesiccation in Simulated Use Journal of the American Academy of Dermatology Dec 1986 Vol 15 No 6 p 1246 3 Sebben Jack E Cutaneous Electrosurgery Year Book Medical Chicago IL 1988 Section 18 Performance Graphs Peak Voltage vs Setting Maximum Open Circuit Voltage 7000 6000 HI a 5000 D E 4000 gt 3000 2 LO 2000 j 1000 BI 0 0 5 10 15 20 25 30 3 Setting Figure 11 Power Out vs Display HI LO Bl at Rated Loads Power Out NO o
16. dea dia doa ee EA oon ati 19 In Cas of Difficulty ii Se a KHON ENS one cal ete so 20 Repair and Return Policy 2 62 ee eee 20 Environmental Protection 0 0 0 ee eee eee eee 20 Specifications yiga gree A ej oy eae 21 SYMBOIS ora o a tached a aa E sabe 22 Index of Reference Material o o o o 23 Performance Graphs ooooooooocoronro eee eens 23 Title Page Front Side and Bottom Panel Controls 0 0 0 0 cc ne 4 Back Panel Controls arsu eaaa had A od Boe haw ead 6 Monoterminal Without a Dispersive Plate Configuration 000 8 Monoterminal with Dispersive Plate Configuration 0 00 00 oo 9 Bipolar Configuration s sssusa anaran ee eee 9 DESICCA ON oroni tee ed ei A ee SG A Ad dee ee 10 Epilation A Minne di aad a 10 F lg rifi n s senesi hea bd daaa ea a A UO a Melee eae EE a od 11 Monoterminal Coagulation oooooooooooooror ee eee 11 Bipolar Coagulation ii a A is AA 11 Peak Voltage vs Seton cies ds E ARA a 23 Power Out vs Display 0 2 eee eee 23 Load Regulation Curves 2 0 cece eee eee eens 24 This page intentionally left blank IN 202000 Introduction Congratulations on your purchase of the CONMED HYFRECATOR 2000 The HYFRECATOR was introduced in 1937 and has become the world leader in office based electrosurgery With the latest model the HYFRECATOR 2000 CONMED has refined the concept and utilized today s technology to produce the fine
17. e HYFRECATOR 2000 The Footswitch plugs into the switching connector at the base of the unit A non switching handle and cord or forceps delivers power to your patient Most Hyfrecator users prefer the convenience and speed of hand switching pencils and footswitches are required only when you use certain specialized electrodes and handles such as forceps or when you require extremely precise activation 6 FOOT NON SWITCHING HANDLE AND CORD Cat No 7 800 6 Identical to standard switching pencil without the power activation and up down buttons This handle can be sterilized and requires the use of a footswitch 7 DISPERSIVE PATIENT PLATE Cat No 7 900 7 Required for Monoterminal coagulation procedures This stainless steel return plate requires no gels or adhesive 8 DISPOSABLE HYFRECATOR PENCIL AND ADAPTER Cat No 137657 for the pencil and 670 3 for the adapter Sterile disposable pencil with 10 foot cord and needle electrode inserted The pencil fits into the reusable adapter which fits into the desired output mode 9 REUSABLE SUCTION COAGULATOR Cat No 137307 Busey Frazier Tip reusable suction coagulator with detachable 10ft cord 10 BIPOLAR FORCEPS A variety of reusable forceps are available for bipolar procedures Ask your Authorized CONMED Distributor for details Forceps require the use of a Bipolar Cord Cat No 7 801 11 11 REUSABLE ELECTRODES A variety of reusable electrodes for particular procedures are av
18. e any accessory equipment The current flows from either the high or low output terminals to the electrode then passes to the patient The electricity completes the circuit by seeking its own ground through the patient to the table and across the floor returning to your unit via the electrical outlet see Figure 3 Monoterminal procedures without a dispersive plate produce desiccation and fulguration Figure 3 Monoterminal Without a Dispersive Plate Configuration Hyfrecator2000 Monoterminal Monopolar with Dispersive Plate Monoterminal applications with a dispersive plate See Figure 4 are less common than monoterminal applications without a dispersive plate Here the high frequency current starts from either of the bipolar terminals then travels through an electrode to your patient where it exits through the dispersive patient plate and returns directly to the unit Monoterminal applications with a dispersive plate improve the coagulation efficiency by providing a better path for the current flow It s use is indicated when more effective coagulation is desired The power setting should be reduced when a dispersive plate is used until the surgeon becomes accustomed to the increased coagulation efficiency that the dispersive plate provides It is important that the dispersive plate has maximum contact area with the patient and that contact is maintained whenever activation occurs Do not allow the patient to break
19. ease the connector press the release button and pull 6 Slide Mode Selector Switch to HI LO or BI as indicated for the procedure NOTE This selection will also preset the power setting last used in that mode These settings are retained even when the unit is turned off 7 Insert the RF Plug for HI or LO operation or the Bipolar plugs for Bipolar operation into the output jack s uncovered by the Mode Selector Switch 8 Insert an Electrolase Disposable Electrode or other Hyfrecator accessory electrode into the active end of the switching handle 9 Turn the on off switch to the on or 1 position The HYFRECATOR 2000 will then begin a self diagnostic test sequence During this time the HYFRECATOR 2000 will perform various function and safety checks These tests consist of a rotating pattern appearing in the Power Output Indicator and four brief beeps before the last used power setting appears NOTE If a fault is detected during these tests a continuous tone will sound and a Fault Code will appear in the Power Output Indicator Refer to Section 12 in this manual if a fault occurs 10 Adjust the power output for the selected mode to the desired wattage using either the Power knob on the front panel or the UP DOWN buttons on the power switching handle This adjustment only affects the selected mode The power output setting will be retained permanently upon activation or after 3 seconds of inactivity NOTE The pow
20. er output controls have a rapid speed feature to make large power changes Rapid speed is engaged by holding down either the up down buttons or by rapid rotation of the power knob Fine adjustment is achieved by brief button presses or by slow power knob rotation 11 The selected output will be sent to the accessory electrode upon pressing either the pencil activation button for handswitching accessories or the footswitch for footswitching accessories Activation is indicated by the blue light and a continuous audible tone Note Tone volume may be set to the desired level but not silenced by the screwdriver adjustment on the rear of the unit 12 When the procedure is complete turn the on off switch to off or 0 position Section 5 Suggestions for First Time Operation Before using the HYFRECATOR 2000 clinically we suggest the following experiment Hold a quarter pound piece of room temperature beef or chicken firmly in hand or place it on a table and touch it with your hand to improve the path of electrical flow Starting with a low power setting experiment as follows If you are not familiar with desiccation fulguration or coagulation please see the Terminology for Procedural Configuration section e Desiccation In the monoterminal without a dispersive plate mode using an Electrolase Tip touch the meat and turn on the current for one to five seconds Use different intensities with the low and the high output te
21. essories in autoclavable packaging or wrap with a cloth e Autoclave at 121 C 250 F 3 C 16 F for 15 minutes minimum 20 minutes maximum e Remove accessories from the autoclave and allow to cool for 30 minutes minimum NOTE It is not advisable to cold sterilize surgical electrodes due to potential corrosion NOTE Non sterile Electrolase Tips are not validated for sterilization Do not attempt to sterilize these tips NOTE Do not sterilize the footswitch Cat No 7 900 4 Section 10 Optional Accessories 1 ELECTROLASE Cat Nos 7 100 12 non sterile Electrolase Sharp 7 100 8 sterile Electrolase Sharp 7 101 12 non sterile Electrolase Blunt 7 101 8 sterile Electrolase Blunt ELECTROLASE TIPS THE SOLUTION TO CROSS CONTAMINATION amp ACCIDENTAL NEEDLE STICKS Contrary to popular belief the use of an electrodesiccator does not self sterilize the electrode For example the British Journal of Dermatology reported that Contaminated electrodes with Herpes Simplex were not sterilized by electrical discharge and virus transfer to skin samples was demonstrated after contact treatment Also according to a recent article in the Journal of the American Academy of Dermatology the use of disposable electrodes can prevent the transmission of hepatitis B and other viral associated infections such as AIDS Electrolase Tips are disposable single use electrodes for use with your HYFRECATOR 2000 The
22. esthetize the areas and carefully identify the vessels Bring the electrode into direct contact with the ruptured arteriole and use a light current Exercise care to avoid excessive tissue damage that could result in perforation of nasal septum For that reason it is inadvisable to treat both sides simultaneously e Granular Pharyngitis Desiccate each point using a mild desiccating current e Nasal Polyps Desiccate these polyps at the base e Hemostasis in Tonsilloadenoidectomy Use either monoterminal or monopolar coagulation The monoterminal technique uses the HIGH output Bleeding is controlled with a sponge dampened with epinephrine Adrenalin 1 1 000 before activation of the electrode Use a ball electrode Cat No 727 as the active electrode Tonsil Tag Destruction Bipolar coagulation using a specialized electrode Cat No 789CC can destroy tonsillar tissue Insert the double needles into the tissue and destroy the tissue between them Turbinate Shrinkage Use either monoterminal or monopolar coagulation The monoterminal mode uses a fine needle with a long insulated sheath Cat No 716 Monopolar coagulation uses the same electrodes along with the Dispersive Patient Plate Cat No 7 900 7 to complete the circuit Proctology Fissure in ano Spray a fairly strong fulgurating current over the involved tissue Healing is prompt but there is some discomfort during the first three days Do not destroy the tissue too deep
23. gle use accessories Used electrosurgical tips should be disposed of as sharp biological hazards per your local and hospital regulations Studies have shown that smoke generated during electrosurgical procedures may be harmful to surgical personnel These studies recommend using a surgical mask and adequate removal of the smoke using a surgical smoke evacuator or other means Interference produced by the operation of the Hyfrecator 2000 may adversely influence the operation of other electronic equipment Regularly inspect accessories for damage In particular electrode cables and endoscopically used accessories should be checked for possible damage to the insulation Use only accessories that have been approved for use with the Hyfrecator 2000 Do not use accessories that fail to meet the minimum peak voltage requirements per Fig 11 Peak Voltage vs control settings It is recommended to use only accessories rated at the maximum peak voltage for a given mode IN 2000 Failure of the unit could result in an unintended increase of output power When used the neutral electrode patient plate should be reliably attached with the entire surface area in contact with the patient s body and as close to the operating field as possible When not in use the neutral electrode should be disconnected from the Hyfrecator 2000 to avoid accidental burns Apparent low output or failure of the Hyfrecator 2000 to function correctly at nor
24. gure 6 Desiccation NOTE Continued electrodesiccation at increased intensity will result in tissue destruction and charring NOTE Epilation by thermolysis is a special form of desiccation where a fine wire electrode product number 714 destroys hair follicle This procedure uses the low terminal at very low power settings see Figure 7 Figure 7 Epilation Application As the power and or time of treatment increases the amount of desiccation also increases You must however consider the effects of the size of the electrode especially when inserting an electrode needle For instance a large diameter needle requires more power and time to produce the same effect as a small needle e Healing Small lesions usually heal completely in one to three weeks First granulation forms on the base then epithelializes A crust forms and sloughs off in seven to ten days Large lesions may produce two to three successive crusts NOTE In an area of good blood supply and abundant subcutaneous tissue healing will be rapid Post Operative Care Small lesions may not require dressing Larger areas of destruction will require antiseptic dressing and medication until the wound is epithelialized As in any surgical procedure large open wounds should be protected against secondary infection 10 Hyfrecator2000 Fulguration Fulguration comes from the Latin word fulgur meaning an act of lightning It is a monoterminal without a d
25. hecking RE Frequency Output Wave Shape Line Regulation Duty Cycle Audio Display Settings Low Output Terminal 0 10 range 10 20 range Bipolar amp High Output Terminals 0 35 range 60 Hz Leakage Mains Power Cord Environmental Operating Temperature Range Relative Humidity Storage Restrictions Approvals Protection 450 KHz 50KHz open circuit Clipped damped sinusoidal 5 at at max power for a 10 line voltage Intermittent 30 sec on 30 sec off Adjustable from gt 45 dba to gt 65 dba at 1 meter 0 1 watt increments 1 watt increments l watt increments 50 microamps max third wire of line cord open 18 AWG 3 105 C 300V IEC 320 C13 connector 10 ft 3m 10 degrees to 40 degrees C 10 to 95 non condensing 40 degrees to 70 degrees C 95 humidity N C UL 544 Medical and Dental Equipment E68077 EN 60601 1 IEC 60601 1 BE Defibrillator Class 1 Specifications subject to change without notice z Hyirecator2000 rs P Speaker Volume Control Section 16 Symbols Power On Off CAUTION To reduce the risk of an electric shock do not remove the back cover of the instrument Refer all servicing to qualified service personnel CAUTION Site is a source of high voltage CAUTION Before using instrument read operating manual Equipment is classified as Type BF it has an internal electrical power source that provides an adequate degree of protection against ele
26. icient Angiomas Capillary Superficial desiccation of fulguration is usually quite successful in treating these lesions The remaining char may be wiped away with a gauze pad e Angiomas Cavernous Electrodesiccation may satisfactorily treat small lesions Multiple needle insertions are usually necessary e Angiomas Spider Electrodesiccation of the centrum from which the telangiectatic vessels radiate cosmetically removes the lesions e Condyloma Acuminatum Venereal Wart Condylomata respond quickly to electrofulguration Anesthesia is generally required and care must be taken to avoid post operative infection in the warm moist genital area Fibroma Light electrodesiccation or fulguration easily destroys small pedunculated fibromas Keratoacanthoma After a deep shave or scoop biopsy for diagnosis the base of this lesion should be electrofulgurated to achieve hemostasis and destroy any residual tumor z INN 2000 Lymphangioma These uncommon tumors may respond to electrodesiccation or fulguration e Molluscum Contagiosum These viral lesions resolve quickly with electrodesiccation Pyogenic Granuloma This loose vascular tissue responds well to electrofulguration Seborrheic Keratoses These are perhaps the most common and most cosmetically annoying skin tumors in adults Their presence is often associated with old age Initial fulguration enables you to easily wipe away the charred remains with a ga
27. ied service personnel on a periodic basis CONMED suggests examination of the unit at least every 12 months NOTE All internal service should be performed by qualified service personnel only External Cleaning To keep your instrument performing at its best external cleaning should be performed on a regular basis To clean the external case of the HYFRECATOR 2000 and the up down switching handle and cord e Moisten a lint free cloth with a mixture of mild soap and water e Clean all external surfaces with this solution Dry all surfaces thoroughly using a clean lint free cloth Soap based solutions rather than harsh chemicals are recommended cleaning agents for the HYFRECATOR 2000 Evaporative solutions are preferred so as to limit exposure of internal electrical components Material characteristics of the unit do not allow for gas steam or cold sterilization techniques Sterilization of Accessories 7 800 5 Handswitching Handpiece NOTE Do not autoclave the power up down switching handle and cord cat no 7 800 5 Sterilization in an ethylene oxide gas sterilizer with EO HCFC mixture has been validated in accordance with EN ANSI AAMI ISO 11135 1994 Medical Devices Validation and Routine Control of Ethylene Oxide Sterilization for the following ETO cycle parameters Condition After removing the used electrode remove any obvious debris accumulated during use from the handpiece and cable with a sponge or towel moistened with
28. ired output terminal and output mode Output displayed will be the last setting used PATIENT PLATE If a patient plate also called neutral electrode or dispersive plate is required or preferred for High or Low mode operation depending upon the surgical procedure simply plug the dispersive plate into this connector RE PLUG Single Pin Accessory Plug Used to connect the HI or LO output terminal to the handle This plug must be connected to an Output terminal for the pencil to deliver current Note that both the Handswitching and Footswitching Pencils use the same RF plug connection POWER UP BUTTON Press this button to increase the power setting for the selected mode continued on next page Hyirecatorzo0o Is Figure 2 Back Panel Controls 15 POWER DOWN BUTTON Press this button to decrease the power setting for the selected mode 16 RELEASE BUTTON To remove an accessory switching connector press this button to release the accessory then pull the connector straight away from the unit 17 FOOTSWITCH Used to activate the unit when a Footswitched Pencil or Bipolar Forceps are used 18 BIPOLAR FORCEPS Must be used with a footswitch for activation 19 FOOTSWITCHED PENCIL Use when footswitch activation is preferred Back Panel Controls 1 VOLUME CONTROL Adjusts volume of the audible tone generated when the power activation button is pressed To increase volume insert a screwdriver and rotate clockwi
29. ispersive plate technique where the electrode is held slightly away from the surface being treated see figure 8 resulting in sparking to the surface When delicately fulgurating you must precisely position the point of the active electrode close to the area being treated or the electrical arc may divert to adjacent tissue areas If desired you can quickly fulgurate broad areas by holding the electrode further from the skin Fulguration limits tissue destruction to a shallow area under the spark and is normally characterized by an eschar Figure 8 Fulguration e Application Factors such as power treatment time electrode size and the moisture content of the tissue influence the area and depth destroyed with one application Additionally the distance between the electrode and the tissue is important Post Operative Care Same as desiccation e Healing Same as desiccation Coagulation Coagulation derives from the Latin word coagulate meaning to clot As seen in Figures 9 and 10 there are two types of coagulation Monoterminal Coagulation Uses the dispersive patient plate also called a return electrode or an indifferent electrode as seen in Figure 9 Bipolar Coagulation A technique where the current flows between two closely placed electrodes as seen with the forceps in Figure 10 A dispersive patient plate is not used Figure 9 Monoterminal Coagulation Figure 10 Bipolar Coagulation 11 Hyirecator
30. lity of shocking during monoterminal applications Do not let your patient come in contact with any grounded metal objects Position the electrode on or close to the patient before activating the output For procedures using the dispersive plate do not allow the patient to break contact with the dispersive plate when the unit is activated e If the physician or nurse must touch the patient place hand on the patient before activating the HYFRECATOR 2000 Do not break contact during activation To lessen the possibility of a shock wear gloves at all times and continue to avoid contact with grounded metal objects Hyfrecator2000 Section 3 Operating Controls and Indicators Figure 1 Front Side and Bottom Panel Controls HAND CONTROL SETUP BIPOLAR SETUP IN 202000 Front Side and Bottom Panel Controls 1 10 11 12 13 14 ON OFF SWITCH Turns unit on or off When the Hyfrecator 2000 is turned on the unit automatically powers up to the setting last used POWER ACTIVATION BUTTON When pressed high frequency energy is emitted from the electrode Additionally an audible tone is generated and the active on indicator light illuminates POWER UP DOWN SWITCHING HANDLE AND CORD Remove or insert the power handle in the indicated direction POWER OUTPUT INDICATOR Displays the power setting for the mode presently selected Each mode automatically retains it s own independent powe
31. ly Instruct your patient to keep the area clean and to apply an antiseptic ointment Hemorrhoids Some authorities advocate bipolar coagulation for office management of hemorrhoids Individually distend the hemorrhoids with a fluid solution and then coagulate e Ischiorectal Incise and drain these lesions then desiccate the wall with strong current Papilloma Small papillomas readily respond by inserting a fine needle electrode but a fairly strong current is needed Larger polyps within the bowel are better treated with snares and an electrosurgical cutting current Urology Bladder Desiccation or fulguration of various growths within the bladder are well established urological techniques Use a cystoscope and a continuous flow of water Check with the manufacturer of your cystoscope to determine compatibility with the HYFRECATOR 2000 e Vasectomy After your patient has been anesthetized the lumen of the vas deferens can easily be desiccated minimizing any peripheral damage to the surrounding muscle layers Venereal Warts Venereal warts and other small polypoid tumors respond to desiccation Insert the sharp fine needle point electrode into the base of the growth intermittently applying the current until the tissue mildly blanches It is not necessary to remove the desiccated tissue as epithelization occurs beneath it z INN y 2000 Section 9 Maintenance The HYFRECATOR 2000 should be tested by qualif
32. mal operating settings may indicate a faulty green wire ground connection This could be due to a faulty power cord loose connections inside the unit the use of a two wire extension cord or the use of a three to two prong adapter These faults can result in a burn if the patient plate is used and is not in good contact with the patient If the neutral electrode patient plate is being used the low power may be due to faulty application or poor contact in its connections In this case the application of the neutral electrode and it s connections should be checked before selecting a higher power Skin to skin contact for example between the arms and body of the patient should be avoided by the insertion of dry gauze or other suitable means When the Hyfrecator 2000 and physiological monitoring equipment is used simultaneously on the same patient any monitoring electrodes should be placed as far as possible from the surgical electrodes Needle monitoring electrodes are not recommended In any case monitoring systems incorporating high frequency current limiting devices are recommended The use of flammable anesthetics or oxidizing gases such as nitrous oxide N 0 and oxygen 0 3 should be avoided if a surgical procedure is carried out in the region of the thorax or the head unless these agents are sucked away or flammable anaesthetic proof equipment is used The Hyfrecator 2000 is not flammable anaesthetic proof equipment Do not use
33. p solutions or drapes oxidizing gases such as Nitrous Oxide N20 or in oxygen enriched environments The risk of igniting flammable gases or other materials is inherent in electrosurgery and cannot be eliminated by device design Precautions must be taken to restrict flammable materials and substances from the electrosurgical site whether they are present in the form of an anesthetic life support skin preparation agent or are produced by natural processes within body cavities or originate in surgical drapes tracheal tubes or other materials There is a risk of pooling of flammable solutions in body depressions such as the umbilicus and in body cavities such as the vagina Any excess fluid pooled in these areas should be removed before the equipment is used Attention should be called to the danger of ignition of endogenous gases Some materials for example cotton wool and gauze when saturated with oxygen may be ignited by sparks produced in normal use of the Hyfrecator 2000 To avoid alternate site burns or potential shock remove all metal objects from treatment area before using the HYFRECATOR 2000 It is not advisable to use this instrument in the proximity of jewelry eyeglasses digital watches portable radios pocket calculators hearing aids etc Do not use monopolar electrosurgery on small appendages or other parts of the body having a relatively small cross sectional area as in circumcision or finger surgery as it can cause
34. r setting that is set when the mode is selected again ACTIVE ON INDICATOR Tlluminates when the power activation button is pressed POWER KNOB Increase power by rotating clockwise decrease power by rotating counter clockwise Power is advanced by one watt increments in High and Bipolar modes and in the Low mode at a power level greater than 10 watts Power is advanced in one tenths of a watt when less than ten watts in the Low mode HIGH OUTPUT TERMINAL Insert the power up down switching handle and cord single pin into this outlet for heavy desiccation and fulguration procedures requiring high intensity Provides between zero and 35 watts with high voltage LOW OUTPUT TERMINAL Insert the power up down switching handle and cord single pin into this outlet for light desiccation and fulguration procedures requiring low intensity Provides between zero and 20 watts with a voltage lower than the high output terminal BIPOLAR OUTPUT TERMINAL For coagulation procedures using forceps When using forceps the forceps plug into both bipolar outlets a footswitch is required when forceps are utilized Bipolar provides between zero and 35 watts with a voltage lower than the high or low output terminals SWITCHING CONNECTOR The power up down switching handle and cord socket plugs into this connector Be sure to align the connector pins before inserting NOTE The optional footswitch plugs into this same connector TERMINAL SELECTOR SWITCH Selects the des
35. rminals Cut the meat open with a scalpel and view the depth of penetration A mild blanching of the tissue is sufficient for most conditions Hyirecatorzo0o rs Fulguration Using either the low or high output terminals bring the electrode near but not touching the meat one to three mm Use various settings and observe the different degrees of fulguration that can be produced Short bursts of a spark alternated with short cooling periods are most acceptable to the patient Continuous application of the spark creates heat that may become intolerable Cut the meat open at the fulgurated spots to view the relatively shallow effect Coagulation If you have purchased the optional cord and dispersive patient plate or the forceps and footswitch you may wish to experiment with the effects of monoterminal and bipolar coagulation You will find that monoterminal coagulation produces very deep effects while bipolar coagulation produces relatively superficial effects A training tape covering basic dermatological procedures utilizing the HYFRECATOR 2000 is included with the unit Additional copies are available from your Authorized CONMED Distributor Cat No 7 900 21 Section 6 Terminology for Systems Configuration Monoterminal monopolar without Dispersive Plate The vast majority of HYFRECATORO 2000 procedures use monoterminal techniques without a dispersive plate They are easily set up provide excellent results and do not requir
36. se until resistance is felt Do not force adjustment past the resistance point For safety reasons the tone cannot be completely turned off 2 WALL MOUNTING STUDS Used with standard wall mounting kit Cat No 7 796 20 see the mounting kit for instructions Instrument may also be mounted on optional mobile pedestal stand Cat No 7 796 1 Note The 7 796 20 mounting kit must be used to mount the unit on the mobile pedestal stand INN 2 210 2000 Section 4 Operation of Your Instrument 1 The Hyfrecator 2000 should be mounted vertically with at least 2 5cm clearance around the top and sides of the unit Approximately 5 13cm should be allowed at the bottom of the unit for access to the accessory connections Adjust the volume to an acceptable level before mounting because the volume control is at the back of the unit Refer to the supplied Wall Mount Kit or optionally the Mobile Pedestal Stand instructions for additional information 2 Verify that the Hyfrecator 2000 is the correct mains voltage and frequency by checking the serial number plate on the back of the unit 3 Plug power cord into connector on the bottom of the HYFRECATOR 2000 4 Plug power cord into a grounded electrical outlet A solid ground is necessary for safe and effective operation of the Hyfrecator 2000 5 Align and insert the four pin connector from the switching handle or the footswitch into the connector on the bottom of the unit To rel
37. st machine of its kind Safe and simple to use the HYFRECATOR 2000 has a wide range of applications from dermatology and gynecology to ophthalmology and urology The HYFRECATOR 2000 s state of the art electronic circuitry utilizes two microprocessors to provide unsurpassed output power accuracy and patient safety Whether it s full power for broad surface coagulation or low power in one tenth watt increments for delicate facial procedures the HYFRECATOR 2000 provides the precision you demand Internal self diagnostic tests are performed every time you turn on the HYFRECATOR 2000 and the power output is monitored continuously during operation This makes the HYFRECATOR 2000 one of the safest office based electrosurgery units in the world Compatible with your existing HYFRECATOR accessories such as bipolar forceps and reusable electrodes the HYFRECATOR 2000 features an ergonomic design and contemporary style that complements modern office decor Section 1 Inspection The CONMED HYFRECATOR 2000 has been thoroughly tested and inspected before shipment from the factory Please check the unit before using for any damage that may have occurred in transit to you If any damage is evident please immediately contact the Authorized CONMED Distributor from whom you purchased the unit In addition please compare the accessories you receive with the standard accessories listed below If an item is missing please notify your CONMED Di
38. stributor To activate your warranty return the enclosed warranty card to CONMED Corporation within 10 days of receipt of your invoice Standard Accessories Description Catalog Number Starter box of Non Sterile Electrolase Blunt Tips 7 101 12 Starter box of Non Sterile Electrolase Sharp Tips 7 100 12 Power Up Down Switching Handle and Cord 7 800 5 Non Sterile Sheaths 7 796 18 Sterile Sheaths 7 796 19 Wall Mount Kit 7 796 20 Operator s Manual and Warranty Card 7 900 OM Common Dermatologic Procedures Videotape 7 900 21 Section 2 Safety Precautions and Warnings Users are warned against the use of the HYFRECATOR 2000 on patients with implants such as metal pins metal joints etc Check with attending physician for patient s medical history before using the HYFRECATOR 2000 The use of the HYFRECATOR 2000 on patients with cardiac pacemakers is potentially hazardous The high frequency energy of the HYFRECATOR 2000 output may interfere with the action of the pacemaker Precautions should be taken to ensure that the patient s well being is maintained in the event of such interference We recommend that the manufacturer of the pacemaker be consulted for advice before using the HYFRECATOR 2000 on a patient with a pacemaker These precautions also apply to clinical personnel with cardiac pacemakers Hyirecator2000 rs Electrosurgery should NEVER be performed in the presence of flammable anesthetics flammable pre
39. thrombosis and other unintended injury to tissue proximal to the surgical site IEC 60601 2 2 3rd Edition indicates the use of bipolar techniques may be desirable for use in those situations in order to avoid unwanted coagulation Note however that AAMI Standard HF18 1993 currently contraindicates both monopolar and bipolar electrosurgery for circumcisions The tips of recently activated accessories may be hot enough to burn the patient or ignite flammable material Temporarily unused active electrodes should be stored in the holder on the Hyfrecator 2000 or in an electrically insulated flame resistant container to prevent injury due to hot tips or accidental activation of the footswitch The unused active electrode should never be placed on the patient The output power selected should be as low as possible and activation times should be as short as possible to achieve the desired surgical effect Electrosurgical leads active bipolar or return should not be allowed to contact the patient staff or other electrical leads connected to the patient When uncertain of the proper control setting for the power level in a given procedure start with a low setting and increase as required Do not place liquid containers on top of the unit Wipe spilled liquids off the unit immediately To prevent inadvertent entry of liquids do not operate this unit except in its normal upright position To prevent cross infection do not reuse disposable sin
40. tion is found to be defective Hyirecator2000 rs Transportation of the HYFRECATOR 2000 must be prepaid by the sender The unit will be returned prepaid to the owner by the same manner of transportation used in shipping the product to the manufacturer The warranty does not apply to any product or integral part thereof that has been altered or serviced by anyone other than the manufacturer Nor does it apply toward any product that has been damaged as a result of accident abuse misuse or negligence on the part of the user Section 12 In Case of Difficulty The HYFRECATOR 2000 has two microprocessors for control and safety functions If either of the microprocessors discovers a problem during the power on self diagnostic check the unit will inhibit operation and display an error code in the power display If an error code appears in the power display window either EO through E9 or 0 through F turn the unit off and wait a few seconds before turning the unit back on This may clear the problem If the error code is E7 either one of the buttons on the Power Up Down Switching Handle was pressed or the footswitch was activated when the HYFRECATOR 2000 was turned on or the accessory is defective Turn the power switch off and disconnect the accessory If the HYFRECATOR 2000 powers up normally without the accessory connected the accessory is defective Replace the defective Power Up Down Switching
41. uze pad or gentle curette The cosmetic result is usually excellent Multiple small seborrheic keratoses of the face in young blacks dermatosis papulosa nigra may be treated without anesthesia using a low power setting While excellent cosmetic results are achievable it is prudent to initially treat one or two as a therapeutic cosmetic test Sebaceous Papules Seen in rosacia and older oily skinned patients these lesions may be removed by light electrofulguration Syringomas Very light fulguration followed by gentle curettage may be curative Test one or two lesions initially as a cosmetic trial Telangiectasias Facial telangiectasias respond well to gentle electrodesiccation Use LOW terminal at low power settings at one or more sites along their length This procedure has several advantages over more costly laser treatments and less controllable sclerosing injections Leg lesions however are more recalcitrant to electrosurgery and more likely to recur Common Warts Verrucae Vulgaris Most common warts respond to electrofulguration and curettage of the base Special care must be given to warts that occur over specifically located nerves Such sites include the digital nerves or those that occur on weight bearing surfaces like the foot Verruca Plantais Care should be taken to avoid excessively deep tissue destruction which may result in painful scarring Filiform Warts Electrodestruction of the pedicle near its base yields a high
42. y offer a safe economical solution to the threat of potential cross contamination or accidental transfer of a virus to you or your staff For your convenience Electrolase Tips are available in both Sharp and Blunt configurations the Sharp configuration is for pinpoint procedures and the Blunt configuration is for broad based coagulation The tips are also available in both non sterile and sterile packaging Non sterile Electrolase Tips should be used in treating patient when a hospital clean environment is satisfactory Sterile Electrolase Tips are available for work requiring a sterile field The HYFRECATOR 2000 comes with a starter box of non sterile Electrolase Sharp Tips and a starter box of non sterile Electrolase Blunt Tips 2 HYFRECATOR PENCIL SHEATHS Cat No 7 796 18 Disposable non sterile clear plastic sheaths protect the pencil body from external contamination during procedures 3 STERILE HANDPIECE SHEATH Cat No 7 796 19 Disposable sterile clear plastic sheaths protect the pencil body from external contamination during procedures z IN 2 10 2000 4 MOBILE PEDESTAL STAND Cat No 7 796 1 Provides the ability to roll the HYFRECATOR 2000 from one location to another The stable five legged steel stand has a durable protective coating This accessory requires the use of the wall mounting kit cat no 7 796 20 5 FOOTSWITCH Cat No 7 900 4 The Footswitch can be used to power activate th
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