DERM 101 and 102 User Guide
Contents
1. The Bovie DERM 101 102 must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected RF Emissions CISPR 11 RF Emissions CISPR 11 Class A The Bovie DERM 101 102 is suitable for use in all establishments other than Class A domestic and those directly connected to the public low voltage power supply network that supplies buildings used in domestic purposes Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions Complies IEC 61000 3 3 12 Bovie Medical Corporation 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 IEC 60601 Electromagnetic environment Immunity test Compliance level test level guidance Electrostatic discharge ESD IEC 6 kV contact 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U2. 30 dip in Ut for 25 cycles lt 5 U gt 95 dip in U for 5 sec 6 kV contact 8 kV air 2 kV for power supply lines Not Applicable 1 kV differential mode 2 kV common lt 5 U gt 95 dip in Ut for 0 5 cycle 40 U 60 dip in Ut for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip in Ut for 5 sec NOTE U is the a c mains voltage prior to application of the test level User s Guide DERM 101 102 Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the Bovie DERM 101 102 requires continued operation during power mains interruptions it is recommended that the Bovie DERM 101 102 be powered from an uninterruptible power supply ora battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Guidance and manufacturer s declaration electromagnetic immunity continued IEC 60601 Immunity test y test level Compliance level Electromagnetic environment guidance Portable and mobile RF c
3. lms Ze DERM 101 Zwi DERM 102 Pi ERoW Hen MAROJE nn Ze DERM 101 Zot DERM 102 User s Guide DERM 101 102 1 TABLE OF CONTENTS TWO 3 Operatind Principle esi epccsccscsensens ceeventacnbeosievessussessc tastes cncenmsarauinsaceresdeisvencasttna verre iden dementerenden 3 SI 3 WE 3 Waminds and Cautions sasmressabeierbniavan rosone anra Ss tansuseoraiarboereeatn asl ONE EN ENON aan aa 3 Sorg iiale lierse gn 6 OU 6 Application 9pecifiCatig ss sse seessssssssssssssssssssssssssssssssssssssssssssssssssssssssnsssssssssssssssnssssssssssssssssssssssssssns 7 On FOG CEO denten 7 Setup Procedures tenoren erneer tenen 8 Performance Checks nennen eneen deere delektinensni deense 10 Ae AESI MCS OEE S EA T angenent annette pokeren db 10 SEO 10 Sterilization and Cleaning of the Accessories ss seesssssssssssssssssssssssssssssssssssssssssssssssssssssssssssns 10 Rie aloe MDT od en 11 EC 11 NGE NCS cenae 11 Wan 14 DOU delle and REDI epesi E A O OA ERS 14 Troubleshooting ww 15 Output Power Characteristics ss ss see ss ssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssssss 16 17 Descriptions of symipols asoortiment tetek 18 2 Bovie Medical Corporation 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
4. CAUTIONS At no time should you touch the active electrode or bipolar forceps A burn could result seeeseeeeeseeeseeeseeseeeseseeeseseesseeeseeseeseeseseeseseeeeeseeeseeseeseeeseeseeseesseeseeeeseeeeseseeseeeeseeseseeseesseseeeseseseeseeseeseseseeseseeeeseeseeeeeseeseeseeseeeseseseeeseeseeesseeseeseeseeeseseeee Do not stack equipment on top of the generator or place the generator on top of electrical equipment These configurations are unstable and or do not allow adequate cooling eccooreccversveevceserveesereevssevevereervcceervecversverveevercveserveesvvecvonecevereerveeservceservcevservevesescevcvcervcrvenecvverveevceservcesevcvevssreecvvereeveeee Provide as much distance as possible between the electrosurgical generator and other electronic equipment such as monitors An activated electrosurgical generator may cause interference with them eeccoorecvverseevcesereceseeeecosercvereevvceeervecvensverveevcervveserveesevervoneevvereerveeserveevervcvsercvevesencvcvcervccvenecvverveevceservcesevcevsseecvveneeveeee Non function of the generator may cause interruption of surgery A backup generator should be available for use Do not turn the activation tone down to an inaudible level The activation tone alerts the surgical team when an accessory is active seeeseeeeeseeeseeeseeseeseseseeeseseesseeseeseeseeseseseseeeeeseeseeseseeseeseeeseeseeseesseeseseeeeseeeeseseeseseeeseesseeseesseseeeseseseeseeseesseseseeseseeeeseeseeseeeeseeseeseeseesee
5. DERM 101 102 produces radio frequency current which is useful for the removal and destruction of superficial cutaneous and mucosal lesions This is done by performing desiccation and fulguration procedures Electrosurgical desiccation occurs when the electrode is placed directly onto the surface of the lesion Fulguration occurs when the electrode is held slightly above the lesion and an arc is delivered to the lesion The unit also provides fast and efficient bleeding control by coagulation of capillaries and small blood vessels For the majority of desiccation fulguration and coagulation procedures utilizing the standard handpiece in the monopolar output the patient plate is optional When used the patient plate will intensify the coagulation properties of the unit and also lessen the opportunity for an electrosurgical burn The optional footswitch adds versatility when using the standard handpiece in the monopolar output as the footswitch allows you to activate the unit by either the handpiece or the footswitch Bipolar outputs are available for those physicians who prefer to utilize bipolar forceps to perform coagulation procedures A footswitch is required when using the bipolar output and the patient plate is not used Procedures that are performed in sensitive areas may require an anesthetic Flammable anesthetics should not be used If you are unfamiliar with the operation of a low powered electrosurgery unit it is advisable to practice on chi
6. 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 POPPE HSE HOSES EEEHHOEEEEO EE ESESE EEE OSEOE TEESE ETE EHOE HEE HOOT E OTOH ES EEEEEEESOSHEESOEHO EE SEHEE TOOTS ES HOEE SOO SEEEEEEOOETEESOOHEEHOSEEEEEEHHOTEOESEHESESESESESEEOEEEESE Avoid HF output settings where maximum output voltage may exceed rated accessory voltage Refer to the accessory s voltage rating POPP S REESE SEES E EES T EEE T EE OEEH EEE EEE EOE EOE TEESE EH SEHH ES EEEEE EE EOEE TES OEETEESEEH EEO OEEE EE EETE ETE OOOO EEEEOEE EE ESEE SEH OEE SEH SEHH EE EEEEE EEL ESEEELEEEE EEE EEE To avoid incompatibility and unsafe operation use suitable cables accessories active and neutral electrodes including values for the highest allowed H F peak voltage seeseeeeeseeeeeseeseeseeseeeseeseseeseseeeeseseeseeeeeseeeeeseeeseeseeseeeseeseeeeseeeeeseeeseeseeeseeeeeseeeseeseeeseseeeseseeeeeeeeseeeeeseseeeeseeseeseeseeeesseeeseseeeeeseeee Connected accessories need be rated for at least the maximum peak output voltage of the H F generator set at the intended output control setting in the intended operating mode eeeeeeeeeeseeseeeeseeseeseseseeeseeseeeeseseeeeeeseseeseeeeseeeeeseeeseeeseeseeseeeseeseeeeeseseseeeseeseeeseeeeseeeseseseeeseeeseeeseeseeseseeeseseeeseeesseseeseeeseeseeeseeeeseeeseeeseeeeseseeseeeeseseeeeeeee The output power selected should be as low as possible for
7. coagulate tissue using RF waveform Power setting is selectable by front panel manipulation of a rotary encoder knob Power and activation are indicated on the unit display Medical Purpose Indication Intended for the removal and destruction of skin lesions and coagulation of tissue Site Condition Clean and protect from infection from start through completion of procedure Bovie Medical Corporation Site of Use Soft tissue skin muscle Patient Population Patient should not be user Age Infant to geriatric Weight gt 2 5kg Patient State Alert relaxed may be sedated having had local anesthetic applied Intended User Profile e Education Trained physician physician s assistant nurse nurse practitioner No maximum Knowledge Minimum Understands electrosurgery and electrosurgical techniques Read and understands supplied User s Guide Accompanying Document Understands hygiene Maximum There is no maximum e Language Understanding Languages are as specified in the marketing distribution plan Experience Minimum Some training on techniques or training under surveillance supervision No special experience needed Maximum There is no maximum Permissible Impairments Mild reading vision impairment or vision correction to 20 20 Partial hearing impairment allowing for audible detection of tones at 0 5 2 0 kHz UNIT OPERATION The Bovie
8. fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location which the Bovie DERM 101 102 is used exceeds the applicable RF compliance level above the Bovie DERM 101 102 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Bovie DERM 101 102 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m WARRANTY The Bovie DERM 101 102 is covered under warranty for a period of two years The handpiece is covered under warranty for a period of one year or 25 steam autoclave cycles whichever comes first The warranty becomes null and void if damage occurs from incorrect handling or misuse of the product SERVICING AND REPAIR It is recommended that all Bovie parts be returned to an authorized Bovie service center On request Bovie will provide circuits diagrams component part lists descriptions and instructions to assist service personnel in parts repair Refer to DERM 101 102 Service Guide For warranty and repair work please contact Bovie and obtain a Return Goods Authorization number RGA Place the number so that it can be seen on the exterior of the package and ship directly to Bovie A return without an RGA may not be accepted 14 Bovie Medical Corporation TROUBLESHOOTING The Bovie DERM 101 102 has been desig
9. 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 coaqulate and desiccate tissue SAFETY The safe and effective use of electrosurgery depends to a large degree on factors solely under the control of the operator There is no substitute for a properly trained and vigilant medical staff It is important that they read understand and follow the operating instructions supplied with this electrosurgical equipment Physicians have used electrosurgical equipment safely in numerous procedures Before starting any surgical procedure the surgeon should be familiar with the medical literature complications and hazards of using electrosurgery in that procedure To promote the safe use of the Bovie DERM 101 102 High Frequency Desiccator this section presents the warnings and cautions that appear throughout this user s guide So that you can operate this equipment with maximum safety it is important that you read understand and follow the instructions in these warnings and cautions It is also important that you read understand and follow the instructions for use in this user s guide C Cox DERM 101 102 Electrosurgical Desiccator Reference No DERM 101 Reference No DERM 102 wal Manufactured by Bovie Bulgaria Ltd Boul Tsarigrad
10. plugged into the forceps A sliding gate behind the monopolar and bipolar outputs prevents the user from using both simultaneously User s Guide DERM 101 102 12 The optional footswitch A803 is plugged into the footswitch output and placed on the floor see figures 2 and 3 letter 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 If contamination has occurred to the handpiece the handpiece should also be sterilized 15 Adjustment of the audible tone is achieved by a switch located on the rear of the unit see figure 4 Two tone choices are available high and low A small screwdriver will be necessary to make the adjustment PERFORMANCE CHECKS Bovie Medical Corporation recommends that you complete periodic inspection and performance testing Perform inspections and performance testing every six months A qualified biomedical technician should conduct this testing to ensure that the unit is operating effectively and safely 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 testi
11. the intended purpose Certain devices or accessories may present a safety hazard at low power settings seeeeeeeeseeeseeseeseesesseeseeeseeeseseeseeseeseeseseseseseeeeseeseeeseeeseeseseseseeeseeseeeeseseseseeseeseeseseeseeseeseseeeseeseeeseeseseeseeeseseseeeseeseseeeseseeseeeeseeseeseseeseeeseseseeeseeseeseseeseeseeeseeeseeeseeee Apparent low output or failure of the Bovie DERM 101 102 to function correctly at the normal operating settings may indicate faulty application of the neutral electrode or poor contact in its connections In this case the application of the neutral electrode and its connections should be checked before selecting a higher output power eeeeeeeeeeseeseeeesseeseeeseseeeseeseeeeeseseeeseeseseeseeeseeeeeseeeseeeseseeeseeeseeseeeeseseseeseeseeseeeseeeeseseeeeseeseeseeseeseeeseeseeeseeseeeseeseeeseeeseseseeeseeseeeeseeseeseeeseeeseeeseeseeseeeeeseeseeeeeeee When using Monopolar mode associated equipment and active accessories should be selected that have a voltage rating of 3 3 kVp or greater seeeeeeeeseeeseeseeseeseseseseeeseseeseseeseeseeseeseseeseseeeeeseeeseeseeeseeseseseseeeeseeseseeeseseseseeseseeseseeseseesseeseseeseeseseeeseseseeseseseseeseseeseeeeseseeseeeseeseeseseeseeseeseseseeeseeseeseseeseeseeeseeseeseeee When using Bipolar mode associated equipment and active accessories should be selected that have a voltage rating of 1 kVp or greater seeeseeeeeseeeeeseeseeeseeseeeseeseseeseseeeeseseeseeeeeseeeeeseeeseeseese
12. to earth Volume control lt a Explosion Risk if used with flammable anesthetics Manufacturer Mandatory Refer to instruction manual guide OEG 07 Compliant RoHS Directive 2011 65 EU RalS Compllart tomano Fuse type and rating Slow blow T high capacity H gt Conforms to European Union medical Directives 93 42 ECC and its revision 2007 47 EC 18 Bovie Medical Corporation 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 User s Guide DERM 101 102 20 Bovie Medical Corporation es Manufactured by BOVIE BULGARIA Ltd 1784 Sofia Bulgaria Boul Tsarigradsko shose No133 Building 3 fl 3 5 International Phone 359 2 9813650 C Eom Distributed by BOVIE MEDICAL CORPORATION 5115 Ulmerton Road Clearwater Florida 33760 USA U S Phone 1 800 537 2790 e Fax 1 800 323 1640 International Phone 1 727 384 2323 www boviemed com MC 55 229 001 REV 1 2014 06 10
13. 100 50 Figure8 Bipolar Mode Waveform Er YOKOGAMA Oi Nov 2013 1851246 Normal Edge CH3 F 416 V RnonA 5400 as var EIM5 s Auto Mem We 20 div 2 10 f I Power 100 6 Power 50 4 lilin AT AT taris bns HIT HEELT weeen RAW Www Www servi 2 r r r rar Max C3 1000 V P PC3 1244 V Rms C3 98 5760 V Mean C3 1 11153 V 0 Frea C3 19 53186Miz 200 400 600 800 1000 Impedancel0 Figure 9 Output Power versus Load Monopolar 100 50 Figure 10 Monopolar Mode Waveform EE pn YOKOGAMA O Mow 2013 185101 Normal Edge CHI F OA l GD 10a ka ban i ES Huis 2 10 g 8 6 4 Power 100 Power 50 4 wm yn yi Iwema i vann JW el Maxita 3 OPK P P C3 3 BBW Rms C3 299 046 V Mean C3 9 77874 V Frea ta 19 531252 0 0 500 1000 1500 2000 Impedance 0 User s Guide DERM 101 102 17 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 AN O ZHAO gt gt en gt I Non ionizing radiation Neutral Electrode referenced
14. 8mm x 7 2 184mm x 2 7 69mm Weight lt 3 Ibs IEC CLASSIFICATIONS IEC 60601 1 Degree of protection against ingress of water Ordinary Equipment IEC 60601 1 Equipment not suitable for use in the presence of flammable mixtures EMC COMPLIANCE The precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual Understand that only the Accessories supplied with or ordered from Bovie Medical should be used with your device The use of Accessories transducers and cables other than those specified may result in increased Emissions or decreased Immunity of the Bovie DERM 101 102 The Bovie DERM 101 102 and its accessories are not suitable for interconnection with other equipment User s Guide DERM 101 102 11 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 The Bovie DERM 101 102 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Bovie DERM 101 102 can help preven
15. cken or lean flank steak to visualize the effects at various output and power levels SETUP PROCEDURES 1 Mount the Bovie DERM 101 102 on the wall or optional mobile stand using the standard mounting kit see figure 1 Do not operate the unit in the horizontal position as liquids may spill into unit 2 Plug the female end of the power cord into the base of the unit see figures 2 and 3 letter A 3 Plug the male end of the power cord into a grounded wall receptacle User s Guide DERM 101 102 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 Slide the standard electrode into the handpiece until it is firmly seated see figures 2 and 3 letter C The handpiece will accept most standard 2 electrodes 6 Slide the handpiece into the holder on the left side of the unit before powering on the unit 7 Turn the unit power on utilizing the switch on the right side panel of the unit see figures 2 and 3 letter D 8 Bovie Medical Corporation ZZ DERM 101 71 IE Figure 3 8 Set the power output either by using the dial o
16. ed Standard Accessories Applied Parts Catalog Description Quantity Models A902 3 button handpiece 1 pcs All models A804 Sharp Dermal tip Non Sterile 5 pcs All models A805 Sharp dermal tip sterile 2 pcs All models A806 Blunt dermal tip non sterile 5 pcs All models A807 Blunt dermal tip sterile 2 pcs All models Catalog Description Models See Catalog Bipolar Forceps non sterile Recommended DERM 102 only A827V Bipolar Forceps Cord Recommended DERM 102 only 10 Bovie Medical Corporation Catalog Description Quantity Models A802EU Reusable Grounding Pad Recommended All Models A837 Wall Mount Kit 1 pcs All models A910 Disposable handpiece sheath non sterile 2 pcs All models 09 064 001 110 VAC Hospital grade power cord 1 pcs For 110VAC models only 220VAC cord to be shipped only with special order units IP 55 229 User s Service Manual CD 1 pcs All models NOTICES A902 Handpiece shall be used with the DERM 101 102 Only Bipolar accessories are for use with the DERM 102 Only TECHNICAL DESCRIPTION Mains Connection Safety Main Voltage 100 240 VAC 10 Basic Construction In accordance with EN 60601 1 Main Frequency 50 60 Hertz Mode of Operation Intermittent operation Main Current 320mA Max Protection Class CLASS EQUIPMENT Power Consumption 28 VA Output Type TYPE BF Duty Cycle 10sec on 30sec off Main Fuses T 400mAH 250V Dimensions and Weight Length x Width x Height 8 2 20
17. eeeeseeeseseeeeeseeeeeseeeseeeeeseeseeseeeseseeeseseeeeseeeeseeeeeseseeeeseeseeeseeseeeesseeeseseeeeeseeee Studies have shown that smoke generated during electrosurgical procedures can be potentially harmful to patients and the surgical team These studies recommend adequately ventilating the smoke by using a surgical smoke evacuator or other means seeeseeeeeseeeeeseeseeeseeseeeseeseseeeseseeeeseseeeseeeeeseeeeeseeeseeseeseeeseeseeeseseeeeeseeeseeseeeseeeseeseeeseeseeeseseeeseseeeeeeeeseeeeeseseeeeseeseeseeseeeeseseeeseseeeeeseeee 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 CONTRAINDICATIONS There are no known contraindications NOTICES If required by local codes connect the generator to the hospital equalization connector with an equipotential cable Do not clean the generator with abrasive cleaning or disinfectant compounds solvents or other materials that could scratch the panels or damage the generator CATALOG NUMBERS The Bovie DERM 101 102 has 2 models DERM 101 and DERM 102 DERM 101 Monopolar mode only unit with 110 VAC Hospital grade power cord DERM 102 Monopolar amp Bipolar modes unit with 110 VAC Hospital grade power cord APPLICATION SPECIFICATION Description e A 10 Watt RF desiccator used to
18. ernal or external devices such as pacemakers or pulse generators Interference produced by the use of electrosurgical devices can cause devices such as pacemakers to enter an asynchronous mode or can block the pacemaker effect entirely Consult the device manufacturer or hospital Cardiology Department for further information when use of electrosurgical appliances is planned for patients with cardiac pacemakers or other implantable devices If the patient has an Implantable Cardioverter Defibrillator ICD contact the ICD manufacturer for instructions before performing an electrosurgical procedure Electrosurgery may cause multiple activation of ICDs Do not use electrosurgical equipment unless properly trained to use it in the specific procedure being undertaken Use by physicians without such training has resulted in serious unintended patient injury including bowel perforation and unintended irreversible tissue necrosis 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 Associated equipment and active accessories should be selected that have a rated accessory voltage equal to or greater than the maximum output voltage In some circumstances potential exists for alternate site burns at points of skin contact e g between the arm and the side of the body This occurs when e
19. ioned 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 The use of flammable anesthetics or oxidizing gases such as nitrous oxide N20 and oxygen 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 Non flammable agents should be used for cleaning and disinfection wherever possible Flammable agents used for cleaning or disinfecting or as solvents of adhesives should be allowed to evaporate before the application if HF surgery There is a risk of pooling flammable solutions under the patient or in body depressions such as the umbilicus and in body cavities such as the vagina Any fluids pooled in these areas should be mopped up before HF surgical 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 HF surgical equipment eeeeseeeeeseeeeeseeseeeseeseeeseseseeseseeeeseseeseeeeeseeeeeseeseeseeseseeeseeeseseseeeeseeeseeseeeseeeeeseeseeseeeseseseeseseeeeseeeeseeseeeseeeeeeseeseeeseeseeeeseseeseseeeeeseeee
20. lectrosurgical current seeks a path to the return electrode that includes the skin to skin contact point Current passing through small skin to skin contact points is concentrated and may cause a burn This is true for grounded ground referenced and isolated output generators To reduce the potential for alternate site burns do one or more of the following Avoid skin to skin contact points such as fingers touching leg when positioning the patient e Place 5 to 8 cm 2 to 3 in of dry gauze between contact points to ensure that contact does not occur Position the return electrode to provide a direct current route between the surgical site and the return electrode which avoids skin to skin contact areas e 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 recommends the use of split return electrodes and Bovie generators with a contact quality monitoring system Minor neuromuscular stimulation is possible when arcs between the ACTIVE ELECTRODE and tissue occur The generator has been designed to minimize the possibility of neuromuscular stimulation The entire area of the neutral electrode NE should be reliably attached to the patient s body and Bovie Medical Corporation as close to the operating field as possible Refer to NE instructions for use The cables to surgical electrodes should be posit
21. n 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 Power output is displayed in 1 watt increments from 0 1 to 10 watts Figure 4 J Switch O O Volume Selectors rey A DERM 101 BEF NOTICE The output settings can not be adjusted when the unit is being activated 9 To activate the unit remove the handpiece from the holder Place the handpiece in the desired position and depress the activation button see figures 2 and 3 letter K When the unit is activated an audible tone is sounded and the blue active light will illuminate see figures 2 and 3 letter F 10 To use the optional grounding plate with cord A802EU insert the plug of the cord into the grounding plate output see figures 2 and 3 letter G and connect the other end into the grounding plate The plate should be placed underneath the patient at a point where the entire plate is covered by bare skin The use of conductive gel is recommended 11 To use the optional bipolar cord A827V insert the plugs into the bipolar outputs see figures 2 and 3 letter H The cord is then
22. nd may need to be replaced F3 Handpiece Power e Check handpiece for Power Down command Once the Down upon power up command is halted the unit will resolve the error If the error persists the handpiece could be malfunctioning and may need to 5 be replaced Power UP and Power Check handpiece for Power UP Down command Once the Down are command is halted the unit will resolve the error If the error simultaneously persists the handpiece could be malfunctioning and may need to depressed be replaced F Duty Cycle Fault unitis Do not exceed 30 sec activation time for one activation request activated more than 30sec If problems persist the unit should be taken out of service and the manufacturer should be notified For technical support or return authorization phone 1 800 537 2790 User s Guide DERM 101 102 15 Operating Parameters Ambient temperature range 10 to 40 C Relative humidity 30 to 75 non condensing Atmospheric pressure 70kPa to 106kPa If transported or stored at temperatures outside the operating temperature range allow one Warm up time i hour for the generator to reach room temperature before use Transport Ambient temperature range 40 to 70 C Relative humidity 10 to 100 including condensation Atmospheric pressure 50kPa to 106kPa Storage Ambient temperature range 10 to 30 C Relative humidity 10 to 75 non condensing Atmospheric p
23. ned 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 Description of Error Recommended Action Internal Calibration Error Switch unit off and on again DC Supply Over Voltage Switch unit off and on again Detection 36V Make sure unit is connected to correct power source for the unit Pulse Width Switch unit off and on again 7 DC Supply Over Voltage Switch unit off and on again Detection 9V e Make sure unit is connected to correct power source for the unit Multiple Errors e Switch unit off and on again The following table lists Bovie DERM 101 102 fault codes their meaning and recommended actions to be taken to resolve the faults The faults are resettable i e it is not necessary to switch unit off and on again to reset the fault condition Fault Code Description of Fault Recommended Action Activation upon power e Check handpiece for activation up e Check footswitch for activation once the activation is halted the unit will resolve the error If the error persists the handpiece could be malfunctioning and may need to be replaced Handpiece Power UP e Check handpiece for Power Up command Once the command upon power up is halted the unit will resolve the error If the error persists the handpiece could be malfunctioning a
24. ng The testing should include checking all modes of operation for proper function and power output MAINTENANCE The Bovie DERM 101 102 requires periodic cleaning When the unit case requires cleaning simply utilize a soap and water solution and wipe clean Be careful to not have any water enter into the unit through the various openings Dry the unit with a clean lint free cloth STERILIZATION AND CLEANING OF THE ACCESSORIES The Bovie DERM 101 102 standard accessories are supplied sterile and non sterile The handpiece may be cleaned and sterilized Refer to the instruction sheet that accompanies the electrode NE and handpiece for specific instructions on cleaning and or sterilization We recommend that all contaminated electrodes and handpieces be sterilized prior to disposal Read the accessories Instructions for Use for additional cleaning disinfection and sterilization details ACCESSORIES The accessories listed below are original Bovie accessories to be used with the Bovie DERM 101 102 Accessories replacement parts and disposable items that are not listed should only be used when their safety and technical suitability have been checked Additional accessories are available from your local Bovie dealer Reusable items must be checked for damage before each re sterilization Accidental burns can be caused by damaged accessories See the accessories Instructions for Use for additional details Supplied or Recommend
25. ntact between the patient and the physician POC POO SESE EE EOE EEE SHEET ESHOO ESO EEE ESE EEE TOE HOES SHEET EE ESEE ES ESOSEEESOOH EES OSEE ES EEHE ETE OES ES HOES OO EEEEE SESE SESE EES OEEEEEEEHE EE EEEEEHTESESESESESSEOEEEEEE The patient should not come in contact with metal parts which are earthed or which have an appreciable capacitance to earth for example operating table supports etc The use of antistatic sheeting is recommended for this purpose POPPE ESET EEEEEHEEEEEEETESHOE ESO EEOE TEESE TEESE E EH EOET EE ESEEE HOSES ESOEH ESOS EE SOHE ETE EEE OT ESHOEE SOS EOETEEETOETEESOOHEEHOEEEEEEEEEEEEEHEETESEDESES ESSE EEEEE PCP PO CEE OEE EE EEE EEE EEHE TEE EHE EEE O EEE EEE EEE EOE EOE HSE E OEE EEEEEE EEE EEEEEEEOEE TEESE EES EEH ETE EEOE EEE ESESTEOEEE EEE EEEEE TEESE EEE OEEH EE SEHH EEE OESELELESEEELEEEEEEOELE Examine all accessories and connections to the electrosurgical generator before use Ensure that the accessories function as intended Improper connection may result in arcs sparks accessory malfunction or unintended surgical effects Refer to the accessories instructions for use for more detailed instructions Accessories must be connected to the proper receptacle type In particular bipolar accessories must be connected to the Bipolar Instrument output jack only Improper connection may result in inadvertent generator activation User s Guide DERM 101 102 CAUTIONS When not using active accessories place them in
26. ommunications equipment should be used no closer to any part of the 3 Vrms Bovie DERM 101 102 including cables than the Conducted RF a IEC 61000 4 6 150 kHz to 80 3 Vrms V recommended separation distance calculated from the MHz equation applicable to the frequency of the transmitter Recommended separation distance de 25 d 3575 25 80 MHz to 800 MHz de ZJ 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter 3 V m manufacturer and d is the 80 MHz to 3 V m E recommended separation distance in metres m 2 5 GHz Radiated RF IEC 61000 4 3 Field strengths from fixed RF transmitters as determined by an electromagnetic site survey 4should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Ka NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 4 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicated theoretically with accuracy To assess the electromagnetic environment due to
27. ressure 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 OUTPUT POWER CHARACTERISTICS Power readouts agree with actual power into rated load for Coagulation Mode to within 20 or 0 1 watts whichever is greater for Bipolar Mode to within 20 for power settings gt 1W to within 0 3 watts for power settings lt 1W Mode Output Power Output Frequency Repetition Rate Crest Factor Rated Load Vp p Coagulation 10W 10000 550 kHz 44 9 kHz 19 5 kHz 10 10 0 20 3 3 kV Bipolar 10 W 150 0 550 kHz 44 9 kHz 19 5 kHz 10 10 0 20 1 0 kV 16 Bovie Medical Corporation 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 Figure 5 Output power versus power setting for all modes Figure 6 Power setting versus voltage Vpeak for all modes RI 12 peak KV monopolar mre Vpeak kV bipolar 10 E ad 7 2 6 E amp EER Ee 2 0 0 2 4 6 8 10 12 pce acta i Powerset E _ a _ Figure 7 Output Power versus Load Bipolar
28. rom power source to isolate the internal circuits from the supply mains User s Guide DERM 101 102 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 Failure of the high frequency electrosurgical equipment could result in an unintended increase of output power The instrument receptacles on this generator are designed to accept only one instrument at a time Do not attempt to connect more than one instrument at a time into a given receptacle Doing so will cause simultaneous activation of the instruments Use the lowest output setting necessary to achieve the desired surgical effect Use the active electrode only for the minimum time necessary in order to lessen the possibility of unintended burn injury Pediatric applications and or procedures performed on small anatomic structures may require reduced power settings The higher the current flow and the longer the current is applied the greater the possibility of unintended thermal damage to tissue especially during use on small structures Use electrosurgery with caution in the presence of int
29. sko shose No133 Building 3 fl 3 and fl 5 1784 Sofia Bulgaria for Bovie Medical Corporation WARNINGS AND CAUTIONS In order to safely operate the Bovie DERM 101 102 several precautions need to be followed WARNINGS Hazardous Electrical Output This equipment is for use only by trained licensed physicians Danger Fire Explosion Hazard Do not use the Bovie DERM 101 102 in the presence of flammable materials Fire Explosion Hazard The following substances will contribute to increased fire and explosion hazards in the operating room Flammable substances such as alcohol based skin prepping agents and tinctures e Naturally occurring flammable gases which may accumulate in body cavities such as the bowel e Oxygen enriched atmospheres e QOxidizing agents such as nitrous oxide N 0 atmospheres The sparking and heating associated with electrosurgery can provide an ignition source Observe fire precautions at all times When using electrosurgery in the same room with any of these substances or gases prevent their accumulation or pooling under surgical drapes or within the area where electrosurgery is performed To avoid risk of electric shock this equipment must only be connected to a supply mains with protective earth Connect the power cord to a properly polarized and grounded power source with the frequency and voltage characteristics that match those listed on the back of the unit Disconnect power cord f
30. sseeseeeseeeeseseseeseseeeeeeeee When using a smoke evacuator in conjunction with the electrosurgical generator place the smoke evacuator a distance from the generator and set the generator volume control at a level that ensures that the activation tones can be heard seeeseeeeeseeeseeeseeseeeseseeeseseeseseeseeseeseeseseeseseeeeeseeeseseeseeseeeseeseeeseseeseeeeseeeeseseeseeeeseeseesesseseeeseseeseseeseesesseseseeseseeeseseseeseeeseeeseeeseeseeeseseseeeseeseeseseeseeseeseeeseeseeee The use of high frequency current can interfere with the function of other electromagnetic equipment When high frequency surgical equipment and physiological monitoring equipment are used simultaneously on the same patient place any monitoring electrodes as far as possible from the surgical electrodes Monitoring systems incorporating high frequency current limiting devices are recommended seeeseeeeeseeeseeeseeseeesseseeeseseeseeeseeseeseeseseeseseeeeseeseeseseeseeseeeseeseeeseseeseseeeeeseeeeseseeseeeeseesseeseesseseeeseseseeseeseeseseseseeseeeeeseeseeseeeeseeeseeseeseeseeseseeeseeeesseeseeseseeeseeeseeee Do not use needles as monitoring electrodes during electrosurgical procedures Inadvertent electrosurgical burns may result To avoid the possibility of an electrosurgical burn to either the patient or the physicians do not allow the patient to come in contact with a grounded metal object during activation When activating the unit do not allow direct skin co
31. t electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Bovie DERM 101 102 as recommended below according to the maximum output power of the communications equipment Rated maximum output power of Separation distance according to frequency of transmitter in metres m transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz w d 12 VP d 12 VP d 23 VP 0 12 0 12 0 23 0 38 0 38 0 73 1 2 1 2 2 3 3 8 i 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Guidance and manufacturer s declaration electromagnetic emissions he Bovie DERM 101 102 is intended for use in the electromagnetic environment listed below The customer or the user of he Bovie DERM 101 102 should assure that is used in such an environment Emissions test Compliance Electromagnetic environment
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