User Manual
Contents
1. 1 1 System DescriptiOn in ni petes ritate 1 2 Principle of Operation rere edited 1 3 2 INDICATIONS FOR USE CONTRAINDICATIONS Indications for Use re im m eret ble rie 2 1 ConitraindicatiOrls rccte cbr bota 2 1 3 SAFETY Operating Personnel 3 1 Fire Explosiom Warnings noe rne 3 1 Electrical Safety 3 1 EMC Precautions ssie itai que E Ede oue 3 2 Electrosurgical Smoke Caution sss 3 2 Prior to Surgery e ete tercio duree ree ceu Redes 3 2 During SUGE 3 3 After Surgery icit Hen nie Cen idee tc Heer da 3 4 4 System DESCRIPTION VAPR Generator it e oriri ve 4 1 Output Mades adeo UIROS 4 1 Generator Controls and 4 3 Front Panel Display Symbols tttm 4 4 FOOtSWItCh aid ert tee d niae Eee vere datas 4 5 VAPR Electrodes uscito teneas 4 8 VAPR Handpiece and 4 10 5 INSTRUCTIONS FOR UsE System InstallatiOri rr 5 1 System Setup and Use During Surgery 5 5 Using TC2. VAPR SYSTEM SYSTEM DESCRIPTION 4 8 3 5 End Effect Electrode The forward facing spring electrode is designed to facilitate controlled precise tissue effects Additionally side extensions of the insulator minimize undesired collateral tissue contact 3 5 90 Hook Electrode The 90 hook electrode is designed to provide tissue cutting Use of the hook as a probe should be avoided 2 3 Side Effect Electrode The side facing active tip is designed to maximize tissue contact area and produce rapid tissue debulking The 2 3 configuration is particularly useful in engaging tissue that cannot be approached using the 3 5 electrode 2 3 End Effect Electrode The forward facing active tip is designed to facilitate controlled precise tissue effects 2 3 Temperature Control End Effect Electrode A soft tissue desiccation device utilization with a VAPR 3 system allows tip temperature of the electrode to be indicated on the generator display Intended use is for coagulation of soft tissues in patients requiring arthroscopic surgery of the knee shoulder ankle elbow and wrist 2 3 Wedge Electrode The 45 angled active tip is designed to facilitate controlled precise tissue effects Additionally the side extension of the insulator will minimize undesired collateral tissue contact VAPR SYSTEM VAPR HANDPIECE AND CABLE The
3. 0 5 7 Adjusting the Tone Volume sse 5 7 Adjusting the Footswitch Handpiece Option 5 8 Changing Electrodes During 5 8 Use of suction 5 9 After SUG ORY s bp ipe et esi 5 9 6 CLEANING AND STERILIZATION PROCEDURES Cleaning the Generator eie eee tret edunt ine Cleaning the Footswitch Cleaning and Sterilizing the Handpiece and Cable 6 1 Steam Sterilization Procedure 6 1 7 PERIODIC MAINTENANCE 5 22 2 7 1 8 ERROR AND FAULT SYMBOLS TROUBLESHOOTING GUIDE Error and Fault Symbol Interpretation 8 1 Error Symbols i re rtt tte e esee Eae dua venae eed Sect 8 1 Fault Symbols acd 8 1 Troubleshooting Guide e tee 8 2 APPENDIX A TECHNICAL SPECIFICATIONS A 1 APPENDIX B 022222 00 1 B 1 VAPR SYSTEM Section 1 INTRODUCTION BACKGROUND Arthroscopy relates to the use of an arthroscope to visualize the joint space most commonly of the knee shoulder ankle elbow and wrist A variety of instrumen
4. Note 1 Desiccate Full Power 120W Load Ohms 3A Limit prevents 10R measurement Note 2 Internal Limiting 10R Output VAPR SYSTEM TECHNICAL SPECIFICATIONS A 3 VAPR Il AND Peak Output Voltage at Open circuit 240Va c vs Output Control Setting 1200 22 5 900 v2 i v ae 600 E 300 DES 0 0 50 100 150 200 Output Control Setting OUTPUT WAVEFORM AND CHARACTERISTICS VAPR 3 ONLY TECHNICAL Waveform The RF output is a variable amplitude sinusoid SPECIFICATIONS waveform varying between approximately 340k Hz and 450kHz corresponding to minimum A 4 and maximum load impedance respectively Crest Factor V1 V2 V3 BV1 BV2 and Desiccate A nominal crest factor of 1 4 for all outputs Power Maximum power 260 watts into 160 ohms Max Voltage V1 254V RMS V2 307V RMS V3 340V RMS BV1 307V RMS BV2 340V RMS Desiccate 120V RMS VAPR TC Desiccate 100V RMS NOTE The following load curves apply to the fundamental power delivery capability of the generator alone They do not imply a given power output for any given electrode and cable configuration when used with the generator Each accessory will self impose an upper set power limit for the generator the value of which will be equal to or below the maxium power delivery capability of the generator VAPR SYSTEM VAPR 3 ONLY HALF Power 130W LOAD CURVE LOAD CURVE 240v a c RF POWER OUTPUT 130W
5. DePuy Mitek a company VAPR SYSTEM User Manual 126063 G REF 103097 Rev J 03 07 DePuy Mitek a company VAPR SYSTEM User Manual This user s guide will familiarize you with the controls and output functions available from your Mitek VAPR System and instruct you on the proper use of the equipment Review this manual thoroughly before installation and use of the VAPR System Please also read understand and follow all cautions and warnings in this manual and those included in the Instructions for Use included with the VAPR System accessories Additional information training and product servicing are available from Mitek The information contained in this manual is based upon the most current information available at the time of printing Mitek reserves the right to update the equipment and its operation without notice The entire content of this manual is the property of Mitek and is protected by all relevant copyright laws Do not reproduce any portion of this manual in any form without express written approval of Mitek Worldwide Patents pending 126063 G REF 103097 Rev J 03 07 This manual covers both the VAPR II and VAPR System Except where otherwise indicated the instructions for use apply to both systems VAPR SYSTEM TABLE OF CONTENTS 1 INTRODUCTION aM TEE 1 1 Comparison to Conventional Electrosurgery
6. ONLY Inlet Fuses Time lag 6 3A T6A3 VAPR 3 ONLY Leakage Currents Within limits of Class BF equipment as per IEC 60601 1 VAPR SYSTEM Alarm Volume Adjustable between 40dB minimum and 65dB maximum at 1m This is an activation signal only Classification Electrical Class 1 ordinary equipment as per IEC60601 1 EMC Group 1 Class A as per IEC60601 1 2 Defibrillator Proof Type BF equipment with isolated F applied part Each of the electrode terminals of the Generator can withstand the effects of defibrillator discharge Liquid Spillage as per IEC 60601 2 2 The Generator enclosure will prevent reasonable amounts of liquid from interfering with the Generator s safe and satisfactory operation Intermittent Operation The Generator is cooled by natural convection Under maximum power setting and rated load conditions the Generator is suitable for a 10 seconds on 30 seconds off duty cycle for 1 hour Temperature Control Mode Control range 45 95 Display range 10 99 Over temp indicator gt 8 above SET temperature TECHNICAL SPECIFICATIONS VAPR FOOTSWITCH SPECIFICATIONS CAT No 225003 amp 225023 A 2 Rating IPX8 OUTPUT WAVEFORM AND CHARACTERISTICS VAPR Il ONLY Waveform The RF output is a variable amplitude sinusoid waveform varying between approximately 340kHz and 450kHz corresponding to minimum and maximum load impedance respectively Crest Factor V1 V2 V3 BV1
7. Visually inspect the Handpiece and Electrode to ensure that they are clean and dry and free of damage prior to inserting the Electrode Damage to the connectors or the presence of fluid may cause a hazardous electrical short Ensure that the Electrode is fully seated in the handpiece prior to use Improper connection could result in non activation of the Electrode and fluid leakage which may produce an electrical short Ensure that electrodes with integrated cables are properly connected to the generator and that the correct default settings are displayed Introducing the Electrode without an instrument cannula may result in tissue injury and or product damage Do not insert withdraw or touch the active tip of the Electrode when power is being applied When not in use place the active Electrode in a clean dry nonconductive and highly visible area not in contact with the patient Inadvertent activation while in contact with the patient may result in burns Operator Safety Cautions The VAPR 3 system contains an over current alarm If this is heard during activation the electrode and handpiece must be withdrawn and inspected for damage An accessory that causes repeated over current alarms when not in contact with a metal surface object should be discarded Maintain the generator volume control to a level that will be audible in a normal operating room environment The activation tone is heard while the foot pedal
8. MAX is the loudest CONNECT CRBLE Indicates that the Generator is waiting for the Electrode Handpiece DESCRIPTION Cable to be attached to the front panel receptacle 4 4 INSERT ELECTRODE Indicates that the Generator is waiting for an Electrode to be inserted into the Handpiece Not displayed when using the electrode with integrated cable NOTE Mode selection can only be performed after an Electrode and Handpiece are connected to the Generator If the Mode button is quickly pressed and released the next user set up option appears OUTPUT SHORTED VAPR 3 ONLY May appear if the active tip shorts against nearby metal objects A warning tone will also be issued Press the mode button on the front panel or the third footswitch button to resume operation for TC electrodes only For all other electrode types operation will resume automatically when the short is removed provided foot pedal remains depressed FOOT MENU OFF VAPR 3 ONLY Indicates that the Footswitch menu option is in the default off position VAPR SYSTEM FOOTSWITCH VAPR Il ONLY The 2 pedal Footswitch FIGURE 4A connects to the VAPR Generator and has two activation pedals Depressing the yellow pedal activates the selected Vaporization V or Blended Vaporization BV outputs Depressing the blue pedal activates the Desiccate DES output to produce hemostasis or thermal modification of tissue Depressing both footswitches s
9. administrations may allow with whatever additional measures necessary the installation and use of class A ISM equipment in a domestic establishment or establishment connected directly to domestic electricity power supplies VAPR SYSTEM Guidance and Manufacturer s Declaration Electromagnetic Emissions The VAPR GENERATOR is intended for use in the electromagnetic environment specified below The customer or the user of the VAPR GENERATOR should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions Group 1 The VAPR GENERATOR uses RF energy CISPR 11 only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby elec tronic equipment RF Emissions Class A The VAPR GENERATOR is suitable for use in CISPR 11 all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic Emissions Class A IEC 61000 3 2 Voltage Fluctuations Complies Flicker Emissions IEC 61000 3 3 SYSTEM DESCRIPTION Guidance and Manufacturer s Declaration Electromagnetic Immunity The VAPR GENERATOR is intended for use in the electromagnetic environment specified 5 2 below The customer or the user of the VAPR GENERATOR should assure that it is used in such an environment Immunity Test IEC 60601 Compliance Elect
10. DES 60W 1 1 Output power VAPR3 HALF POWER 140 20 v3 00 2 80 60 V1 40 20 DES 0 200 400 600 800 1000 o Impedance VAPR 3 ONLY FULL POWER 260W LOAD CURVE LOAD CURVE 240 a c RF POWER OUTPUT 260W DES 120W Output power Output W VAPR3 FULL POWER 250 200 150 7 00 m v 50 0 DES 0 200 400 600 800 1000 VAPR 3 ONLY POWER LINEARITY 160 ohm v3 VAPR3 LINEARITY 250 200 150 100 50 0 0 50 100 150 200 250 Set power W SYSTEM TECHNICAL SPECIFICATIONS A 5 Attention consult accompanying documents Non ionizing radiation This equipment intentionally emits RF energy during activation TECHNICAL SPECIFICATIONS Defibrillator proof type BF equipment This equipment provides a degree of protection against A 6 electric shock to TYPE B as defined in IEC 60601 1 This equipment has an F type applied part capable of withstanding the effects of defibrillator discharge This symbol indicates the conductor that may be used to provide potential equalization between the equipment and the installations busbar VAPR SYSTEM Appendix B WARRANTY The manufacturer warrants the products listed below to be free from defects in material and workmanship under normal use and service for the period s set forth below The manufacturer s obligation under this warranty is limited to the repai
11. Power Frequency 3 A m 3 A m Power frequency magnetic fields 50 60 Hz Magnetic should be at levels characteristic Field of a typical location in a typical IEC 61000 4 8 commercial or hospital environment NOTE Ur is the a c mains voltage prior to application of the test level VAPR SYSTEM Guidance and Manufacturer s Declaration Electromagnetic Immunity The VAPR GENERATOR is intended for use in the electromagnetic environment specified below The customer or the user of the VAPR GENERATOR should assure that it is used in such an environment Immunity Test IEC 60601 Compliance Electromagnetic Environment Test Level Level Guidance Conducted RF 3 Vrms Portable and mobile RF communications equipment IEC 61000 4 6 150 kHz to 80 MHz should be used no closer to any part of the VAPR GENERATOR including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Radiated RF 3 Vrms IEC 61000 4 3 80 MHz to 2 5 GHz Recommended Separation Distance d 1 17 NP 1 17 80 MHz to 800 MHz 2 33 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m SYSTEM DESCRIPTION Field strengths from fixed RF transmitters as determined by an electromagnetic site survey 5 3 should be less th
12. between activations Ensure that the Electrode tip is completely surrounded by irrigant solution during use e Outflow is important especially in small joint spaces Prolonged or unnecessary activation when not in contact with tissue may result in unintentional damage to surrounding tissue AFTER SURGERY WARNING Electric shock hazard Turn off the Generator and unplug the power cord from the AC source prior to cleaning Generator Equipment Disposal The VAPR System Generator contains electronic printed circuit assemblies At the end of the useful life of the equipment it should be disposed of in accordance with any applicable national or institutional related policy relating to obsolete electronic equipment Dispose of any system accessories according to normal institution practice relating to potentially contaminated items VAPR SYSTEM SAFETY 3 4 Section 4 SYSTEM DESCRIPTION VAPR GENERATOR The Generator FIGURE 3 is an isolated output radiofrequency generator that provides power for soft tissue vaporization cutting and coagulation during arthroscopic surgical procedures Technical specifications are detailed in Appendix A OUTPUT MODES The VAPR Generator allows the user to select one of the following functional modes a tissue Vaporization mode or a Blended Vaporization mode that combines Vaporization and Desiccation using generator set up options with the selected output mode activat
13. connecting a VAPR Electrode with Integrated Handpiece VAPR SYSTEM USING VAPR TC ELECTRODES When attaching the VAPR TC electrode the generator will automatically configure itself in temperature control mode the display will indicate the default SET temperature and desiccation power The vaporization output is inhibited pressing the yellow pedal will have no effect II ONLY The SET temperature may be adjusted from its default using the yellow Up Down buttons Similarly the Desiccation power may be adjusted using the blue Up Down buttons on the generator VAPR 3 ONLY The SET temperature may be adjusted from its default using the yellow Up Down buttons Similarly the Desiccation power may be adjusted using the blue Up Down buttons on the generator These settings may also be changed through the menu button adjustment procedure described in section 4 Power SET and mode adjustment can only be made when the generator is not activated During activation the display will change from the SET temperature to the actual measured TIP temperature The system will only deliver power up to the limit indicated on the display Occasionally during high interjoint flow conditions the desired SET temperature cannot be reached If this occurs increase the power from its default setting in small increments until correct temperature control is possible For user convenience an over temperature indicator is operational in t
14. that both the active and return electrodes are located on the surgical instrument thus minimizing the amount of tissue involved in the electrical circuit Problems potentially encountered when using conventional bipolar electrosurgery include limited power delivery and visualization of the working tip tissue sticking and dependence upon proper electrode to tissue orientation Additionally conventional bipolar electrodes do not operate effectively while immersed in conductive irrigating solutions used in arthroscopy such as normal saline or Ringer s lactate In contrast VAPR bipolar electrosurgery Electrodes are specifically designed to function in conductive irrigating solutions The VAPR return electrode is mounted on the shaft of the instrument and does not have to be oriented to be in contact with tissue during use This eliminates the need for a separate patient ground electrode Additionally since only the tissue that is in contact with the active electrode is involved in the electrical circuit the recognized safety features of bipolar electrosurgery are preserved VAPR SYSTEM INTRODUCTION 1 1 SYSTEM DESCRIPTION The VAPR System is designed to provide soft tissue ablation vaporization contouring cutting and hemostasis of blood vessels during arthroscopic surgical procedures The components of the Mitek VAPR System Figure 1 are individually described in Section 4 of this manual e VAPR Generator VAPR Handpi
15. Accessory Fault invalid electrode configuration TROUBLESHOOTING GUIDE The following troubleshooting guide describes potential problem causes and suggested operator solutions If the suggested actions do not resolve the problem please contact technical service Problem Suggestions Solutions No output power Check Handpiece Cable connections Check Electrode connection Contact technical service VAPR SYSTEM ERROR AND FAuLT SYMBOLS TROUBLESHOOTING GUIDE 8 2 Problem Suggestions Solutions Generator resets during activation Fault Symbol 100 10 Ensure no contact was made with other equipment during activation Check grounding of Generator Check Handpiece insulation Check integrity of Electrode Red warning indicator illuminates Contact customer service Unable to activate the Generator Check footswitch for damage Ensure correct footswitch is connected Alarm tone too loud or too quiet Readjust volume using the mode switch Generator will remember the last volume setting used No display on the Generator Generator displays CONNECT CABLE symbol when Handpiece Cable is inserted Request assistance from qualified service engineer if fault persists Check inlet fuses replace with correct type See Service Manual for fuse specifications Contact customer service if problem persists Remove connector and inspect pins for damage Check that connector is fully inserte
16. BV2 and Desiccate A nominal crest factor of 1 4 for all outputs Power Maximum power 200 watts into 160 ohms Max Voltage V1 254V RMS V2 307V RMS V3 340V RMS BV1 307V RMS BV2 340V RMS Desiccate 120V RMS VAPR TC Desiccate 100V RMS NOTE The following load curves apply to the fundamental power delivery capability of the generator alone They do not imply a given power output for any given electrode and cable configuration when used with the generator Each accessory will self impose an upper set power limit for the generator the value of which will be equal to or below the maxium power delivery capability of the generator VAPR SYSTEM ONLY Power Linearity 160 Ohm Load V3 2 240 110 B 150 o 5 100 a o 2 2 2 50 gt 0 0 50 100 150 200 into 160 ohm load Power Setting Generator W VAPR ONLY HALF Power 100W LOAD CURVE Load Curves 240V a c RF Power Output 100W DES 60W 100 v3 80 V2 60 5 V1 5 40 20 DES 0 10 100 1000 Impedance Ohms Desiccate at Half Power 60W VAPR ONLY FuLL Power 200W LOAD CuRvE Load Curves 240V a c RF Power Output 200W DES 120W 200 150 5 100 y3 5 v2 vi 50 0 DES 10 100 1000 Impedance Ohms
17. Handpiece Electrode FIGURES 6 AND 7 is ergonomically designed to facilitate user comfort and control during use The reusable Handpiece Electrode and Cable connects the disposable Electrode with the VAPR Generator The Handpiece and Cable are supplied Non Sterile and must be sterilized prior to each use Sterilization instructions are provided in Section 6 of this manual FIGURE 6 CONNECTOR PLUG WORKING TIP CONNECTOR CABLE ELECTRODE SHAFT SYSTEM ELECTRODE DESCRIPTION CONNECTOR 4 10 FIGURE 7 WORKING TIP 2 gt A ELECTRODE CABLES AND PLUG N p NWR VAPR SYSTEM Section 5 INSTRUCTIONS FOR USE NOTE The Manufacturer is responsible for safety reliability and performance of equipment only if e Installation procedures in this manual are followed Assembly operations extensions readjustments modifications or repairs are carried out by persons authorized by the manufacturer and the electrical installation of the relevant operating room complies with the local codes and regulatory requirements governing such facilities The equipment is used in accordance with these instructions The Mitek VAPR System unit has been designed as a system with accessory features specifically designed to maximize safety and effectiveness Use only the Mitek Handpiece and Electrodes with this System INSTRUCTIONS For Use SYSTEM INSTALLATION 1 Place th
18. ION ERROR AND Most technical problems are indicated by either an Error or a Fault symbol that FAULT SYMBOLS appears in the Generator display window TROUBLESHOOTING GUIDE An Error symbol indicates an accessory malfunction or a Generator component failure that requires servicing of the equipment These symbols 8 1 include a code number to be used by Mitek technical service to diagnose why the system failed A Fault symbol indicates a transient non hazardous event and can be corrected by resetting the system ERROR SYMBOLS An Error symbol is displayed as two alternating messages ERROR XXX REF YYY INTERNAL FAILURE WARNING An error symbol indicates an equipment malfunction which may be hazardous Disconnect all accessories and switch the Generator off Switch the Generator back on and if the self test is completed satisfactorily as evidenced by the CONNECT CABLE symbol in the display the failure occurred in the accessories which should be discarded and replaced If the self test fails then all functions will be inhibited and no attempt should be made to use the Generator Contact Mitek customer service for assistance FAULT SYMBOLS A Fault symbol is displayed as two alternating messages FAULT XXX REF YYY TEXTUAL MESSAGE where TEXTUAL MESSAGE relates to the type of fault NOTE Remember to take note of the fault code for reporting to customer service before completing the reset VAPR SYSTEM The g
19. POWER TEMPERATUR DISPLAY E DISPLAY DISPLAY DISPLAY FAULT INDICATOR ON OFF SWITCH FOOTSWITCH CONNECTOR MODE CONNECTOR CABLE FUNCTION FOOTSWITCH RECEPTACLE 3 RECEPTACLE ENABLE DESICCATE POWER 3 PIN 4 PIN ADJUSTMENT SET 2726 VAPR II ONLY ONLY TEMPERATURE MODE SELON DESCRIPTION 4 2 EQUALIZATION TERMINAL AC POWER INPUT HEAT SINK FUSE HOLDER FIGURE 3 VAPR SYSTEM GENERATOR CONTROLS AND DISPLAYS D gt a NOTE Power Switch The power switch turns AC power on and off When the Generator is on the green light within the power switch is illuminated It is advisable to switch off the Generator whenever it is not in use to avoid any possibility of inadvertent activation Red Warning Light This light will illuminate to indicate a Generator critical failure or a VAPR accessory malfunction NOTE The light will illuminate briefly during the self test routine This is normal and does not indicate a failure Mode Button Depressing the mode button once will enable selection of the mode using the Power Up and Down buttons in the Desiccate blue section Once the display shows the desired V or BV output mode holding the Mode Button down will return the Generator to a Ready condition Power Up Down The Power Up and Down buttons adjust the default power setting the Yellow Arrow button controls the Vaporization V and Blended Vaporization B
20. R can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the VAPR GENERATOR as recommended below according to the maximum output power of the communications equipment Rated Maximum Separation Distance According to Output Power of Frequency of Transmitter Transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 023 074 233 m 7 38 11 67 11 67 23 33 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 SYSTEM DESCRIPTION NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies 5 4 NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people VAPR SYSTEM 3 Insert the power cord into the Power Cord Receptacle on the back of the Generator A standard hospital grade power cord is necessary for proper connection of the Generator to the power source To ensure user safety the Generator must be properly grounded through the power cord and power outlet Connect the power cord from the Generator directly to
21. V outputs in standard electrodes and set tip temperature with TC electrodes and the Blue Arrow buttons control the Desiccate DES output Press the appropriate button once for a power increment or decrement Holding down the button accelerates the incrementation or decrementation Power can only be adjusted with the Generator in Ready mode afier an Electrode is properly connected to the Generator The VAPR Electrode will determine its own default output power and set temperature EE e DI Power Temperature Setting Display The display is divided into separate yellow and blue sections The yellow section left side displays the nominal output power in watts for the selected Vaporization or Blended Vaporization modes or set temperature in TC electrodes The blue section right side displays the nominal output power in watts for the Desiccate output When an output is activated the power display for the selected output flashes and an audible tone sounds For a VAPR TC electrode the actual measured TIP temperature is displayed VAPR SYSTEM SYSTEM DESCRIPTION 4 3 FRONT PANEL DISPLAY SYMBOLS OUTPUT YEL Indicates that the output mode for yellow pedal activation can be selected FOOTSLUITCH Indicates that the footswitch is the activation source for the system ALARM VOLUME Indicates that the audio alarm output level may be selected MIN is the lowest VAPR II ONLY volume available
22. an AC source The Generator is designed to operate as shipped with full regulation between 90 132 VAC or 198 264 VAC at 50 60 Hz This allows the Generator output to remain constant in case of brownouts or power surges WARNING The power cord must meet all requirements for safe grounding Its purpose should not be defeated by using extension cords multiple plug points or three pronged to two pronged adapters Power cords should always be grasped by the plug Do not pull the cord itself 5 Connect the Footswitch to the receptacle on the front of the Generator Press the Generator power switch to the ON position Verify that the green light in the switch illuminates When the Generator is first switched on prior to Electrode connection a system self check sequence will be initiated Verify that the CONNECT CABLE is flashing on the display prompt on the front of the Generator This completes the Generator installation procedure Turn the generator power switch OFF when not in use SYSTEM SETUP AND USE DURING SURGERY VAPR Il ONLY II System Component Requirements A properly installed II Generator with attached 2 pedal Footswitch A Sterile VAPR Handpiece and Cable or VAPR Electrode with Integrated Handpiece A Electrode appropriate to the procedure being undertaken VAPR 3 ONLY VAPR 3 System Component Requirements A properly installed VAPR 3 Generator with attached VAPR 3 Footswitch A Steril
23. an the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz 800 MHz 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 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 predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the VAPR GENERATOR is used exceeds the applicable RF compliance level above the VAPR GENERATOR should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the VAPR GENERATOR Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m VAPR SYSTEM Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the VAPR GENERATOR The VAPR GENERATOR is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the VAPR GENERATO
24. d Check for damage to Cable Generator displays Ensure the connector contacts are clean and dry pau INSERT ELECTRODE symbol and have not been damaged during reprocess TROUBLESHOOTING after Electrode is inserted ing GUIDE Check Electrode integrity Ensure that only Mitek approved Electrodes are being used 8 3 Generator overheats Fault Symbol 300 10 Ensure ambient temperature is within operating limits Allow Generator to cool down before re use Check sufficient ventilation provided around Generator Accessory Fault Fault Symbol 300 14 Contact may have been made with other equip ment during activation such as the scope or other instrumentation Note this may also occur when activation occurs in close proximity to such instruments Remove the electrode from the joint and inspect the accessories for damage Check the accessories by activating the elec trode immersed in irrigating fluid contained in a bowl or similar remote from patient contact before proceeding with surgery If the fault recurs first replace the electrode and check as above If the fault remains replace the handpiece and check as above If the fault continues contact Mitek Customer Service VAPR SYSTEM Problem Suggestions Solutions Output Shorted VAPR 3 ONLY When working in a joint cavity the electrode tip may make contact with metallic instrumentation close to the operative site As a safet
25. d decipherable and that the front panel markings and symbols are still legible Retract the fuse drawer of the mains inlet connector and verify that both fuses are intact and match the rated current and breaking characteristics as per the back panel label Verify that the resistance between the earth terminal of the mains inlet connector and the Generator enclosure is within the limits defined in IEC 60601 1 or the corresponding national standard as applicable Switch on the Generator ensuring that the initial internal self test completes normally as reported on the front panel display Check that the audio alarm front panel warning indicator and vacuum fluorescent display are functioning normally via the user verification sequence which follows initialization Check that the enclosure earth leakage current is within the limits for Class equipment as prescribed with IEC 60601 1 or the corresponding national standard as appropriate Measure the patient earth leakage currents and ensure it is within the limits of BF type equipment as defined within IEC 60601 1 or a corresponding national standard Details of these tests should be recorded in an equipment log with the date of test for future reference Contact Mitek customer service should a unit fault be suspected VAPR SYSTEM PERIODIC MAINTENANCE INSPECTION 7 1 Section 8 ERROR AND FAULT SYMBOLS TROUBLESHOOTING GUIDE ERROR amp FAULT SYMBOL INTERPRETAT
26. e Generator on a table cart racking system or other stable platform 5 1 that can be positioned as close as possible to the operative site during use 2 Provide at least four inches of space from the rear of the Generator Never cover the Generator or stack other equipment on top of it other than in a standard cart system Ensure adequate ventilation as it is normal for the Generator to become warm during use CAUTION EMC CONSIDERATIONS Provide as much separation as possible between the generator and other electronic equipment such as monitors When activating the generator unintended electromagnetic coupling may cause interference with the other equipment Should any unintentional effects appear upon other equipment when using the generator repositioning the generator the connecting leads or other equipment may alleviate the problem It may also help to use different mains supply sockets for any affected equipment The generator should not be used adjacent to or stacked with other electrical equipment If adjacent or stacked use is necessary both the generator and other equipment should be observed to verify normal operation in the configuration in which it will be used The EMC classification of the VAPR 3 system class A is suitable for use on dedicated supply systems not connected to the public mains network such as hospitals NOTE Although class A limits have been derived for industrial and commercial establishments
27. e VAPR Handpiece and Cable A VAPR Electrode appropriate to the procedure being undertake NOTE The VAPR Handpiece and Cable are supplied NON STERILE Refer to Section 6 of this manual for sterilization instructions prior to use Press the Generator power switch to the ON position Verify that the green light in the switch illuminates and that the system self check sequence is initiated Verify that the CONNECT CABLE symbol is flashing on the Generator display indicating that the Generator is in idle mode Inside the sterile field pass the plug end of the sterile Handpiece Electrode Cable out of the sterile field and connect it to the front of the Generator VAPR SYSTEM INSTRUCTIONS For Use 5 5 4 Verify that the INSERT ELECTRODE symbol is flashing on the Generator display indicating the Handpiece is properly connected to the Generator 5 Connect the VAPR Electrode to the Handpiece as shown in FIGURE 8 Once connected the INSERT ELECTRODE symbol flashing on the Generator display will change to the default settings for that Electrode style umm INSTRUCTIONS FOR USE FIGURE 8 NOTE 5 6 The Default Power settings used for the intended arthroscopic procedures vary with the size and or configuration of the active electrode In the Desiccate mode increasing or decreasing the Default Power settings will determine the level of performance In the Vaporization and Blended Vapori
28. e active electrode to cause tissue desiccation and coagulation without sparking or cutting The Desiccation power level is also automatically set as a default for each style of Electrode The Blended Vaporization mode of operation provides tissue vaporization combined with hemostasis Certain Electrode styles will automatically default to a Blended Vaporization mode INTRODUCTION n the Desiccation Mode with temperature indication only available with the VAPR Temperature Control TC electrodes the tip temperature is set as a 1 3 default along with a power level The VAPR System will monitor the actual tip temperature while activating automatically adjusting the power to maintain the tip temperature at the set temperature NOTE The Temperature Control system will only automatically adjust the power up to the limit of the current displayed desiccate power level ELECTRODE SHAFT RETURN ELECTRODE INSULATOR ACTIVE TIP ELECTRODE VAPOR POCKET FIGURE 2 VAPR SYSTEM Section 2 INDICATIONS FOR USE CONTRAINDICATIONS INDICATIONS FOR USE The Mitek VAPR System is intended for resection ablation and excision of soft tissue and hemostasis of blood vessels in patients requiring arthroscopic surgery of the knee shoulder ankle elbow and wrist Arthroscopic surgery could include for example the following Knee Shoulder Meniscectomy Labral Tear Resection Lateral Release Synovectomy Chondroplasty Excisi
29. e design provides a large area suction path which attracts difficult to access frond tissue to the tip and helps minimize clogging LDS LPS and VAPR 590 Electrodes The side facing electrode is designed to maximize the tip tissue contact area and provide rapid tissue debulking The electrode has a large tip shaft offset which maximizes tactile feedback and facilitates removal of difficult to reach tissue The integral Suction Port allows bubbles and vaporization products to be removed The design provides a large area suction path which attracts difficult to access frond tissue to the tip and helps minimize clogging Additionally the forward facing end of the manifold may be useful in protecting adjacent structures from inadvertent injury during activation 3 5 Side Effect Electrode The side facing electrode is designed to maximize tissue contact area and produce rapid tissue debulking The active tissue contact electrode is mounted on the side of the working tip with the return electrode extending over the insulator on the opposite side of the active electrode This configuration is particularly useful in engaging tissue which is approached at an acute angle Additionally the insulator and return electrode assist in protecting adjacent structures from inadvertent injury during activation The larger contact area of the electrode means that these electrodes also produce effective hemostasis of blood vessels
30. e the mode button until FOOTSWITCH appears on the display Press the Power Up button in the Desiccate blue section until HANDSWITCH appears in the display Press and release the mode button until the display changes to the Ready mode Handswitching is now active To return to footswitch operation follow the above procedure instead selecting footswitch NOTE The footswitch will become inactive when handswitch is selected Switching the generator off will reset the generator to footswitch operation CHANGING ELECTRODES DURING SURGERY An Electrode can be removed from the Handpiece by unlocking the connector assembly and then pulling the Electrode and Handpiece apart Once the Electrode is disconnected the Generator will automatically enter idle mode with the display showing the INSERT ELECTRODE symbol Fit a new sterile Electrode as previously described If the new Electrode has different default settings to the previous Electrode check that the Generator display matches the Electrode default settings specified on the package insert NOTE When switching to or from a VAPR electrode with Integrated Cable the generator will display CONNECT CABLE If the new Electrode has identical default settings to the previous Electrode the Generator will retain the settings previously displayed prior to changing the Electrode Switching the Generator power off will clear all output adjustments WARNING Do not in
31. ece and Cable VAPR Electrodes VAPR VAPR 3 Footswitch Power Cord not provided Use only the Mitek Handpiece and Electrodes with this System FIGURE 1 16 CHARACTER USER DISPLAY AC POWER INPUT FAULT INTRODUCTION INDICATOR GENERATOR 1 2 ON OFF SWITCH ELECTRODE WITH ELECTRODE INTEGRATED CABLE HANDPIECE ASSEMBLY VAPR FOOTSWITCH CONNECTOR CABLE VAPR 3 FOOTSWITCH VAPR SYSTEM PRINCIPLE OF OPERATION The VAPR System offers four bipolar modes of operation Vaporization Desiccation Blended Vaporization and desiccation with temperature indication n the Vaporization mode of operation high frequency power is delivered from the VAPR Generator to the Electrode tip At specific threshold power levels a vapor pocket characterized by an orange glow is created around the active electrode Arcs within the vapor pocket produce vaporization of tissue entering the vapor pocket The Vaporization power threshold for a particular VAPR Electrode is automatically set as a default by connecting the Electrode via the Handpiece to the Generator The default setting for each Electrode type is the optimal power required to produce the desired tissue effect As an inherent safety feature the VAPR System is designed to minimize the power required to sustain the vapor pocket around the active electrode n the Desiccation mode of operation the VAPR Generator delivers high frequency power to th
32. ed using the Yellow footswitch pedal The Desiccation hemostasis mode is activated using the Blue footswitch pedal A brief description of each mode is provided below Vaporization V Modes There are three standard V mode levels V1 V 2 and V3 The least aggressive tissue vaporization is created in the V1 mode while the most aggressive tissue vaporization is created in the V3 mode Desiccate DES Mode The Desiccate mode provides hemostasis of blood vessels without tissue vaporization Available with all Electrode configurations the hemostatic effect will be dependent on the active electrode contact area and power setting The depth of effect for a given Electrode configuration and power setting is dependent upon the application time DES with Temp Indication When in desiccation mode this allows the display of electrode tip temperature and control against a set temperature Blended Vaporization BV Modes There are two Blended Vaporization modes BV1 and BV2 The Blended Vaporization output modes combine tissue vaporization with hemostasis and are useful when cutting or de bulking more vascular tissue structures e BV1 mode automatically switches between a V2 vaporization mode and desiccate hemostasis mode BV2 mode switches between the V3 vaporization mode and desiccate hemostasis mode VAPR SYSTEM SYSTEM DESCRIPTION 4 1 OUTPUT MODE POWER DISPLAY OUTPUT DESICCATE DESICCATE MODE MODE
33. emperature control mode an audible tone will sound if the measured TIP temperature reaches more than 8 C over the SET temperature NOTE Certain conditions may momentarily cause temperature overshoot and trigger the over temperature indicator Once triggered the tone will sound for a minimum of 1 second Possible causes are 1 Excessive power used with low no flow environment 2 Insufficient saline around tip 3 Unstable surgical environment excessive changes in saline flow rate and or volume 4 Incorrect irrigation solution used ADJUSTING THE TONE VOLUME The activation tone volume can be adjusted using the following procedure Press and release the Mode button until VOLUME appears on the display Press the Power Up button in the Desiccate blue section The tone can be verified by depressing the down button of the Desiccate blue power control during selection Press and release the Mode button once more to return the Generator to Ready mode NOTE Familiarize yourself with the two audible output tones to verify output selection as it is often difficult to visualize the activation pedals footswitch during arthroscopic surgery VAPR SYSTEM INSTRUCTIONS For Use 5 7 ADJUSTING THE FOOTSWITCH HANDSWITCH OPTION VAPR Il ONLY NOTE This feature is not available as of the printing of this manual To configure the generator for an optional handswitch accessory use the following procedure Press and releas
34. en or endogenous gases which have accumulated in body cavities An electrosurgical device has the potential for providing a source for ignition Nonflammable substances should be used for cleaning and disinfecting Use of flammable substances such as alcohol based skin prepping agents and tinctures should also be avoided All oxygen connections must be leak free for the duration of the surgical procedure Pathways such as endotracheal tubes must be leak free and properly sealed to prevent oxygen leaks Electrosurgical accessories which are activated or hot from use can be a potential fire hazard if placed near or in contact with flammable materials Some materials such as gauze cotton or wool when saturated with flammable liquids can be ignited by sparks produced during the normal use of electrosurgical devices ELECTRICAL SAFETY CONSIDERATIONS Examine all accessories and connections to the VAPR Generator before use Ensure that the accessories function as intended Improper connection may result in arcing sparking or malfunction of the Electrode or Handpiece any of which can result in an unintended surgical effect injury or product damage Unless specified in the instructions for use accompanying an approved VAPR accessory the VAPR System should only be activated with the working tip of the electrode accessory completely immersed in 0 9 w v 150 mmol l sodium chloride or Ringer lactate solutions For convenience
35. enerator can be reset after a fault occurs by either 1 Depress and release the MODE button once OR 2 Depress both footswitches simultaneously and release both footswitches once VAPR ONLY OR 3 Depress and release the menu reset button VAPR 3 ONLY If this does not resolve the problem contact Mitek customer service A list of all Fault symbols and their descriptions is provided below Fault Symbol Ref Description 100 10 Software failure 100 12 Non volatile memory failure 100 14 Power generation fault on startup 300 10 Internal overheating refer to Troubleshooting Guide 300 12 Out of specification input voltage low 300 13 Out of specification input voltage high 300 14 Accessory Fault refer to Trouble Shooting Guide 300 16 Temperature control system problem 300 20 Unsupported electrode VAPR 3 ONLY 400 10 Footswitch BLUE pedal stuck 400 11 Footswitch YELLOW pedal stuck 400 12 Handswitch INPUT fault 400 13 Menu reset button stuck VAPR 3 ONLY 400 14 Electrode identification circuit fault 400 15 Front panel switch fault yellow UP button 400 16 Front panel switch fault yellow DOWN button 400 17 Front panel switch fault blue UP button 400 18 Front panel switch fault blue DOWN button 400 19 Front panel switch fault MODE button 400 20 Intermittent activation switch 400 21 Accessory thermistor fault open 400 22 Accessory thermistor fault short 400 23
36. ew generator model VAPR 3 ONLY VAPR SYSTEM Appendix A TECHNICAL SPECIFICATIONS In this section typical refers to a specification that is within 20 of a stated value at room temperature 25 C 77 F VAPR ELECTRODE SPECIFICATIONS Overall Length 5 7 8 9 in 14 5 22 5 cm Working Length 3 7 6 5 in 9 5 16 5 cm Shaft Diameter 0 06 0 18 in 1 5 4 5 mm Shaft Bend Angle 0 30 TECHNICAL Active Tip Orientation 0 90 SPECIFICATIONS Supplied Sterile and For Single Use Only T Sterilization Method Irradiation VAPR HANDPIECE AND CABLE SPECIFICATIONS Overall Length 10 5 ft 3 2 m Sterilization Method Steam 134 136 C Supplied Non Sterile 20 x Reusable VAPR GENERATOR SPECIFICATIONS Dimensions H x W x D 3 5 in x 16 in x 14 5 in 9 cm x 41 cm x 36 8 cm Weight 12 Ib 5 6kg approximately Transport and Storage Conditions Ambient Temperature Range 32 to 122 F 0 to 50 Relative Humidity 10 to 90 non condensing Atmospheric Pressure 500 to 1060 millibars Operating Conditions Ambient Temperature Range 60 to 104 F 10 to 40 C Relative Humidity 10 to 90 non condensing Atmospheric Pressure 500 to 1060 millibars Power Supply Regulation Voltage 90 132 Volts RMS 198 264 Volts RMS Operating Range nominal 100 120 220 240V RMS 50 60Hz Inlet Fuses Time lag 5A T5A VAPR
37. imultaneously can reset the Generator for fault conditions FOOTSWITCH CONNECTOR FOOTSWITCH CABLE SYSTEM DESCRIPTION 4 5 DESICCATE PEDAL BLUE V BV PEDAL YELLOW FIGURE 4A VAPR SYSTEM FOOTSWITCH VAPR 3 ONLY The VAPR 3 Footswitch FIGURE 4B connects to the VAPR Generator The yellow and blue pedals are used for output activation with the menu reset button for fault clearance or remote adjustment of the output settings if enabled as shown below Depressing the yellow pedal activates the selected Vaporization V or Blended Vaporization BV outputs Depressing the blue pedal activates the Desiccate DES output to produce hemostasis or thermal modification of tissue Depressing the menu reset button can reset the Generator from a fault condition Enabling of Footswitch Setting Feature software version V1 02 onwards n the ready state press the mode function button as shown on Figure 3 three times the display will show FOOT MENU OFF the VAPR 3 system is supplied with OFF as default Press either of the blue arrow buttons to toggle the state until the display indicates FOOT MENU ON Press the mode function button until the generator returns to the ready state When enabled as described above the output settings may be controlled as follows Depressing and releasing the menu reset button when the VAPR Generator is waiting for user interaction
38. is depressed indicating the electrode is activated VAPR SYSTEM f possible avoid the use of needle style electrodes for any physiological monitoring equipment that may be connected to the patient during electro surgery Where practical only use monitoring equipment that incorporates high frequency current limiting devices during electrosurgical procedures The Handpiece or electrode cable should be positioned so that it avoids contact with the patient and any other leads Should a power supply interruption occur the generator power settings will revert to the minimum values when power is re established should the accessory combination still be connected Potential Hazards for Arthroscopic Procedures As visualization may be impaired during arthroscopy be particularly alert to these potential hazards An activated Electrode tip may remain hot enough to cause burns after the electrosurgical current is deactivated Maintain the active Electrode in the field of view at all times Injuries to the patient may result from inadvertent activation or movement of an activated Electrode outside the field of view Use care when inserting and withdrawing the Electrode from a cannula to avoid the possibility of damage to the devices and or injury to the patient Continuous flow of irrigant is recommended Fluid flow assists in removing vaporization by products as well as reducing the temperature of the electrode tip
39. isassemble the Electrode and Handpiece Dispose of the SINGLE USE VAPR Electrodes Prepare the Handpiece and Cable for steam autoclave processing IMPORTANT Disconnecting the Electrode Handpiece will automatically result in the CONNECT CABLE idle mode symbol The Generator can be left in this mode between cases but at the end of the operating session must be switched off from the power supply VAPR SYSTEM Section 6 CLEANING AND STERILIZATION PROCEDURES CLEANING THE GENERATOR The VAPR Generator cannot be sterilized The Generator surfaces can be cleaned with a non abrasive cleaning agent Do not allow fluids to enter the Generator connectors CLEANING THE FOOTSWITCH The VAPR Footswitch cannot be sterilized The Footswitch surfaces can be cleaned with detergents and disinfectant cleaners according to standard hospital practices NOTE The use of strong alkali detergents or cleaners must be avoided as these may damage the device CLEANING AND STERILIZING THE VAPR HANDPIECE AND CABLE 1 Remove all gross matter blood mucous tissue by wiping each component with a cloth or gauze pad and a mild cleaning solution or blood dissolving detergent NOTE The accessories are delicate surgical instruments Do not immerse in reprocessing solutions Do not use abrasive cleaning agents Product damage may otherwise result 2 Rinse thoroughly in running water 3 Allow the Handpiece to drain thoroughly 4 Remove residua
40. ited to the aggregate purchase price for the goods sold by the manufacturer to the customer There are no warranties which extend beyond the terms hereof The manufacturer shall not be liable hereunder or elsewhere in connection with the sale of this product for any indirect punitive or consequential damages or lost profits If the tamper proof seal on the Generator is broken this warranty will be voided This warranty and the right and obligations hereunder shall be construed under and governed by the laws of the Commonwealth of Massachusetts USA The manufacturer reserves the right to make changes in equipment built and or sold by it at any time without incurring any obligation to make the same or similar changes on equipment previously built and or sold by them The products listed above are exclusively manufactured for Mitek in the United Kingdom Manufactured for DePuy Mitek by GYRUS Medical DePuy Mitek a fohmonsfohmon company EU Representative DePuy International Ltd St Anthony s Road DePuy Mitek Inc 325 P tDri C e Beeston e 0086 is 1511 Raynham MA 02767 USA UK 1 800 356 4835 Tel 444 113 270 0461 Fax 444 113 272 4101 VAPR SYSTEM WARRANTY B 1
41. l cleansing agents with a damp cloth 5 Dry the accessory devices thoroughly before sterilizing STEAM STERILIZATION PROCEDURE Wrapped Pre Vacuum Cycle 134 to 136 C for 3 to 4 minutes Drying times may vary with the type of wrapping material Please refer to the sterilizer manufacturer for recommended drying times e After any sterilization and cleaning process check the Handpiece for any damage e g crush damage cracking or distortion Discard if damage is observed WARNING The Mitek Handpiece and Cable is intended for 20 reuse cycles only Exceeding the recommended number of uses may result in electrical or mechanical failure during use or difficulty when assembling or disassembling the Electrode with the Handpiece VAPR SYSTEM CLEANING AND STERILIZATION PROCEDURES 6 1 Section 7 PERIODIC MAINTENANCE INSPECTION The manufacturer recommends that the VAPR Generator be regularly inspected to ensure continued safety of operation throughout its service life The following safety checks should be performed at least every 12 months by a qualified person who has adequate training knowledge and practical experience to perform such tests Inspect the Generator and the Footswitch for obvious signs of mechanical damage or wear Ensure that the Generator case shows no sign of tampering There are no user serviceable items within the Generator or Footswitch Check that the Generator back panel label is present an
42. nce of a conventional return pad the VAPR System should still be treated as a high power electrosurgical device CAUTION Failure of the HF SURGICAL EQUIPMENT could result in an unintended increase of output power Operator Safety Warnings Observe extreme caution when using electrosurgery in close proximity to or in direct contact with any metal objects The majority of arthroscopes and arthroscopic instruments are metal Do not activate the electrode while any portion of the electrode tip is in contact with another metal object localized heating of the electrode and the adjacent metal object may result in product damage Do not wrap Handpiece Footswitch or Generator power cord around metal objects Wrapping cables around metal objects may induce currents that could lead to shock fire or injury to patient or surgical personnel During an electrosurgical procedure the patient should not be allowed to come into direct contact with grounded metal objects such as surgical table frame instrument table etc SAFETY Confirm proper default generator power settings before proceeding with surgery Always check that the automatic default settings shown on the display match those indicated on the package insert of the Electrode being used 3 3 Caution should be used when overriding the default power settings Use the lowest power setting and the minimum tissue contact time necessary to achieve the appropriate surgical effect
43. ne low release a Press menu button fourth time hold for 2 Operative Mode Ablation Desiccation beeps low high release To reset to Operative mode from anywhere within the menu process press and hold menu button for 2 seconds screen will go blank release button SYSTEM 2 26 DES 45 4 7 FIGURE 5A FIGURE 5c VAPR SYSTEM VAPR ELECTRODES The family of VAPR Electrodes has been designed to facilitate access and control the delivery of energy to the joint space Each Electrode contains an internal classification code which automatically adjusts the VAPR Generator to the optimal output power setting The VAPR Electrode has an integrated return electrode on its shaft eliminating the need for a conventional patient ground pad Angled Electrode styles are also available to facilitate tissue access and positioning during use The working tips of the Electrodes can be divided into seven main functional types according to the geometry of the active electrode and insulation support VAPR S90 Electrode The forward facing active tip is designed to facilitate controlled precise tissue effects The RF probe with angled shaft is intended to be used for removal of soft tissue during Arthroscopic procedures in smaller more difficult areas of the anatomy to access such as the knee i e posterior horn of meniscus The integral Suction Port allows bubbles and vaporization products to be removed Th
44. on of Scar Tissue Synovectomy Acromioplasty ACL Debridement Bursectomy Plica Removal Subacromial Decompression Meniscal Cystectomy Chondroplasty Ankle Elbow Fracture Debridement Synovectomy Excision of Scar Tissue Tendon Debridement Synovectomy Chondroplasty Chondroplasty Wrist Synovectomy Cartilage Debridement Fracture Debridement CONTRAINDICATIONS The Mitek VAPR System is contraindicated in any non arthroscopic surgical procedure and in procedures where saline or Ringer s lactate is not used as an irrigant The System is also not appropriate for patients for whom an arthroscopic procedure is contraindicated for any reason Use of the System is also contraindicated in patients with heart pacemakers or other electronic device implants VAPR SYSTEM INDICATIONS FOR UsE CONTRAINDICATIONS 2 1 Section 3 SAFETY OPERATING PERSONNEL The surgeon using this device should be trained in arthroscopic surgical procedures be aware of the risks associated with those procedures have current knowledge of technological advances in surgical products and techniques WARNING Hazardous Electrical Output This equipment is capable of producing a physiological effect SAFETY and is for use only by licensed physicians trained in the use of this device 3 1 FIRE EXPLOSION WARNINGS As with all electrosurgical devices do not use in the presence of flammable anesthetics or oxidizing gases such as nitrous oxide oxyg
45. r or replacement at its sole option of any product or part thereof which has been returned to it or its Distributor within the applicable time period shown below after delivery of the product to the original purchaser and which examination discloses to the manufacturer s satisfaction that the product is defective This warranty does not apply to any product or part thereof which has been repaired or altered outside the manufacturer s factory in a way so as in the manufacturer s judgment to affect its stability or reliability or which has been subjected to misuse neglect or accident The warranty periods for the components of the Mitek Electrosurgical System are as follows Generator One year from shipment date Footswitch 90 days from shipment date Reusable Accessories 30 days from shipment date Electrodes Single use only THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING WITHOUT LIMITATION THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND OF ALL OTHER OBLIGATIONS OR LIABILITIES ON THE PART OF THE MANUFACTURER The manufacturer neither assumes nor authorizes any other person to assume for it any other liability in connection with the sale or use of any of the manufacturer s products notwithstanding any other provision herein or in any other document or communication The manufacturer s liability with respect to this agreement and products sold hereunder shall be lim
46. ready state will initiate a setting adjustment SYSTEM procedure DESCRIPTION After pressing the menu reset button the first time the VAPR Generator will emit two short beeps and start flashing the vaporize mode power settings on 4 6 the left of display as shown in FIGURE 5A While the power setting is flashing holding down the blue pedal will reduce the value and holding down the yellow pedal will increase it Pressing the menu reset button once more will advance the setting to the vaporize waveform which will start to flash rapidly on the display nd and releasing the yellow or blue pedals will cycle through the availability modifiers FIGURE 5B Pressing the menu reset button again will cause the DES power setting to flash as per FIGURE 5C so that it may be adjusted in the same way as the V BV power Pressing the menu reset button once more resumes the ready state with a static display FIGURE 4B NOTE In some versions of the input footswitch the menu reset button will be replaced by a gray pedal For VAPR 3 systems with software V1 01 the footswitch setting feature is always enabled VAPR SYSTEM Menu Button Modify Yellow Blue Pedal Pedal Press menu button once hold for 2 beeps Ablation Power same tone high release Press menu button second time hold for 2 Ablation Mode beeps high low release V3 V2 V1 BV2 BV1 a Press menu button third time hold for 2 Desiccation Power beeps same to
47. rocedures can be potentially harmful to surgical personnel Use appropriate surgical masks or other means of protection PRIOR TO SURGERY Operator Safety Warnings Electric Shock Hazard Do not connect wet accessories to the handpiece or generator Ensure that all accessories are securely and properly connected Electric Shock Hazard Do not remove or tamper with the Generator housing Contact Mitek technical service for assistance The power cord must meet all requirements for safe grounding Do not use extension cords multiple point plugs or 2 to 3 pronged adapters e Do not reuse or resterilize accessories labeled SINGLE USE as malfunction injury or cross infection may result Operator Safety Cautions Inspect the insulation of all cords for cracks nicks and breaks Inspect all connectors for damaged or missing parts Use default power levels to test Electrode performance Confirm proper default power settings with package insert information before proceeding with surgery Accessories labeled REUSABLE must only be processed according to the recommended procedures provided in this manual Provide as much distance as possible between the electrosurgical generator and other electronic equipment such as monitors because an activated electrosurgical generator may cause interference with them VAPR SYSTEM SAFETY 3 2 DURING SURGERY NOTE For the purposes of safety procedures and despite the abse
48. romagnetic Environment Test Level Level Guidance Floors should be wood concrete Electrostatic 6 kV Contact 6 kV Contact or ceramic tile If floors are Discharge ESD covered with synthetic material IEC 61000 4 2 8 kV Air 8 kV Air the relative humidity should be at least 3096 Electrical Fast 2 kV for Power 2 kV for Power Mains power quality should be Transient Burst Supply Lines Supply Lines that of a typical commercial or IEC 61000 4 4 hospital environment 1 kV for Input 1 kV for Input Output Lines Output Lines Surge 1 kV Differential 1 kV Differential Mains power quality should IEC 61000 4 5 Mode Mode be that of a typical commercial or hospital environment 2 kV Common 2 kV Common Mode Mode Voltage Dips Short lt 5 U lt 5 Ur Mains power quality should Interruptions and gt 95 Dip in UT 295 Dip in UT be that of a typical commercial Voltage Variations for 0 5 Cycle for 0 5 Cycle or hospital environment on Power Supply If the user of the VAPR GENERATOR requires continued Input Lines 40 U 40 U operation during power mains IEC 61000 4 11 60 Dip in Ur 60 Dip in Ur iinterruptions it is recommended for 5 Cycle for 5 Cycle that the VAPR GENERATOR be powered from an uninterruptible 70 Ur 70 power supply or a battery 30 Dip in Ur 30 Dip in U7 for 25 for 25 Cycle 5 96 Ur 5 96 U gt 95 96 Dip in Ur gt 95 Dip in Up for 5 sec for 5 sec
49. sert or withdraw Electrodes while activated Injury and or product damage may result NOTE In the event of a power failure or if the Generator is turned off while an Electrode is connected to the Generator the Generator will default to its lowest output power level 5 watts when power is restored The power can be increased using the Power Up button Recommendations Unless circumstances dictate otherwise use the Electrode default power and mode settings to enhance patient and user safety Remove any tissue buildup from Electrodes to maximize surgical effect Avoid any unnecessary and prolonged Electrode activation to prevent overheating When de bulking or vaporizing tissue apply firm pressure using a progressive surface brushing technique Avoid burying the electrode in the tissue as this could increase debris formation The speed of tissue de bulking will be determined by the output mode selection size and style of the Electrode and application technique VAPR SYSTEM INSTRUCTIONS For Use 5 8 When rapidly de bulking or vaporizing tissue some browning of the tissue can be anticipated This can either be brushed away with a non activated electrode or ablated using gentle application pressure during activation f more than one style of Electrode is used during a procedure the Generator will revert to the default settings defined by each Electrode style Bubbles are produced during tissue vaporiza
50. these will be referred to within the remainder of this manual as normal saline or Ringer s respectively Performance will be suppressed by use of other irrigating solutions such as Glycine Sorbitol Dextrose Mannitol or other solutions containing a non physiological concentration of electrolytes VAPR SYSTEM EMC PRECAUTIONS Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information in the accompanying documents WARNING Portable and mobile RF communications equipment can affect medical electrical equipment WARNING The use of accessories and cables other than those for which the system was designed can significantly degrade emissions and immunity performance WARNING Keep the accessory cables away from cables from other electrical equipment Electrical currents may be induced in the other equipment causing unintended effects WARNING Do not use a monopolar generator accessories simultaneously with the VAPR 3 gen erator Activation of a monopolar generator accessories may cause interference with the VAPR 3 generator resulting in user message changes on the display Before pro ceeding with surgery confirm proper power settings are displayed on the generator Ensure the appropriate output setting is enabled for the desired surgical outcome ELECTROSURGICAL SMOKE CAUTION Studies have shown that smoke generated during electrosurgical p
51. tion which may interrupt surgery by temporarily interfering with vision A continuous flow fluid management system is recommended to prevent accumulation and remove bubbles as well as any particulate products of vaporization from the operative field WARNING Avoid bubble accumulation in the joint space during use The accumulation of bubbles around the working tip of the Electrode will diminish performance and may produce overheating sufficient to damage adjacent structures USE OF SUCTION ELECTRODES SHEATHS Suction electrodes and sheaths are designed to provide improved visibility at the operative site whilst facilitating removal of degradation products To avoid premature clogging of the suction pathways in these devices INSTRUCTIONS For USE Close the pinch roller clamp before insertion of the device into patient 5 9 Open the pinch roller clamp immediately prior to activation ablation Close the pinch roller clamp immediately after device activation ablation The pinch roller clamp should not be opened for tissue modification or the sealing of blood vessels blue pedal use as the suction flow may suck unintended tissue into the device and cause clogging In the case of blocked suction electrodes activation of the device in saline at its maximum power for a few seconds may restore the suction pathway AFTER SURGERY After surgery you need to perform the following e Withdraw the Electrode D
52. ts specifically designed for arthroscopic use may be introduced through separate puncture sites employing the technique of triangulation in order to perform various surgical procedures within the joint space Arthroscopic instruments have been developed to provide specific functions such as tissue removal cutting shaping and coagulation Until recently these instruments have broadly taken one of three forms manual instruments powered instruments and electrosurgical instruments each with respective merits and limitations As a result it is common practice to employ a combination of instruments during an arthroscopic procedure The Mitek VAPR System represents a new and versatile approach to arthroscopy Based on an innovative form of bipolar electrosurgery the VAPR System has been specifically designed to provide a range of arthroscopic surgical modalities including soft tissue ablation electro vaporization contouring cutting and coagulation and temperature indication COMPARISON TO CONVENTIONAL ELECTROSURGERY Conventional electrosurgical systems deliver high frequency electrical current through tissue for the purposes of tissue cutting or hemostasis of blood vessels Monopolar electrosurgery utilizes an active electrode located on the surgical instrument and a separate return electrode applied to the patient Current flow is from the active electrode through the patient to the return electrode Bipolar electrosurgery differs in
53. y measure the generator will immediately terminate activation and show a warning message with a short alarm tone In the case of any short remove the electrode from the joint and inspect the accessories for damage If the foot pedal remains depressed activation will automatically restart following a short period For VAPR 3 variants with older V1 01 software and or the use of TC electrodes the Output Shorted fault may be cleared by depressing either the footswitch or generator mode buttons to restore the system to its ready condition Check the accessories by activating the elec trode immersed in irrigating fluid contained in a bowl or similar remote from patient contact F ors AND before proceeding with surgery If the fault AULT AYMBOES TROUBLESHOOTING recurs first replace the electrode and check as GUIDE above If the fault remains replace the hand piece and check as above e Do not use any accessory that persistently faults If the fault continues contact Mitek Customer Service and discontinue use of accessory Unable to access temperature control mode The Temperature Control mode is only enabled with purpose built TC electrodes with an internal temperature sensing element Footswitch inoperative Check the activation source has not been set to HANDPIECE VAPR Il ONLY Generator Displays UNSUPPORTED TYPE after an electrode is inserted Contact customer service to discuss an upgrade to a n
54. zation modes increasing the power setting above the default will have little incremental effect on performance 6 With the arthroscope inserted into the joint cavity carefully insert the Electrode through the instrument portal under direct vision Avoid the use of excessive force Wherever possible use an instrument cannula for the access portal Maintain the active Electrode in the field of view at all times 7 Press either the yellow or blue pedal of the Footswitch to activate the Electrode YELLOW PEDAL Activates the Vaporization V modes and the Blended Vaporization BV modes depending on output mode selection Activation is accompanied by flashing of the Vaporization or Blended Vaporization power display and a high pitched audible tone BLUE PEDAL Activates the Desiccate DES mode only Activation is accompanied by flashing of the Desiccate power display and an audible tone 8 ONLY Power and mode adjustment can only be made when the Generator is not activated The permissible range of power adjustment is determined by the Electrode style 9 VAPR 3 ONLY Power and mode adjustment can only be made when the Generator is not activated The permissible range of power adjustment is determined by the Electrode style Settings may be altered from the front panel button or via the footswitch menu button as described in section 4 CAUTION Use caution when adjusting Output Mode settings Will not be displayed when
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