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INDICATIONS FOR USE

The DePuy 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:

CONTRAINDICATIONS

The DePuy 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.

Knee

Meniscectomy
Lateral Release
Chondroplasty
Synovectomy
ACL Debridement
Plica Removal
Meniscal Cystectomy

Ankle

Fracture Debridement
Excision of Scar Tissue
Synovectomy
Chondroplasty

Wrist

Synovectomy
Cartilage Debridement
Fracture Debridement

Shoulder

Labral Tear Resection
Synovectomy
Excision of Scar Tissue
Acromioplasty
Bursectomy
Subacromial Decompression
Chondroplasty

Elbow

Synovectomy
Tendon Debridement
Chondroplasty

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Содержание VAPR

Страница 1: ...User Manual English GYRUS P N 126063 HC P N 103097 Rev N Revised 11 2014 2004 2014 DePuy Mitek ...

Страница 2: ...stem accessories Additional information training and product servicing are available from DePuy Mitek The information contained in this manual is based upon the most current information available at the time of printing DePuy Mitek reserves the right to update the equipment and its operation without notice The entire content of this manual is the property of DePuy Mitek and is protected by all rel...

Страница 3: ...This manual covers both the VAPR II and VAPR 3 System Except where otherwise indicated the instructions for use apply to both systems ...

Страница 4: ...R Handpiece and Cable 4 10 5 Instructions for Use System Installation 5 1 System Setup and Use During Surgery 5 2 Using VAPR TC Electrodes 5 4 Adjusting the Tone Volume 5 4 Adjusting the Footswitch Handpiece Option VAPR II ONLY 5 4 Changing Electrodes During Surgery 5 5 Use of suction Electrodes 5 6 After Surgery 5 6 6 Cleaning and Sterilization Procedures Cleaning the Generator 6 1 Cleaning the F...

Страница 5: ...ctrical 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 that both the active and return electro...

Страница 6: ...vidually described in Section 4 of this manual VAPR Generator VAPR Handpiece and Cable VAPR Electrodes VAPR VAPR 3 Footswitch Power Cord not provided Use only the DePuy Mitek Handpiece and Electrodes with this System FIGURE 1 Introduction 1 2 AC POWER INPUT 16 Character User Display Fault Indicator Control Panel Connector Cable Handpiece Assembly Electrode VAPR Footswitch On Off Switch Generator V...

Страница 7: ...pocket around the active electrode In the Desiccation mode of operation the VAPR Generator delivers high frequency power to the 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 he...

Страница 8: ...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 Knee Meniscectomy Lateral Release Chondroplasty Synovectomy ACL Debridement Plica Removal Meniscal Cystectomy Ankle F...

Страница 9: ...al 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 SAFE...

Страница 10: ...commended that a suitable extraction method is employed 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 DePuy Mitek technical service for assistance The power cord must meet all ...

Страница 11: ...d the minimum tissue contact time necessary to achieve the appropriate surgical effect 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 connecti...

Страница 12: ...ay 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 o...

Страница 13: ...ve 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 Elect...

Страница 14: ...T TEMPERATURE UP DOWN ADJUSTMENT EQUALIZATION TERMINAL heat sink AC POWER INPUT fuse holder desiccate power up down adjustment and mode selector MODE FUNCTION FOOTSWITCH ENABLE FAULT indicator output mode display output mode power display SET TIP TEMPERATURE DISPLAY desiccate mode display desiccate power display 3 pin VAPR II only 4 pin VAPR 3 only ...

Страница 15: ...g the Yellow Arrow button controls the Vaporization V and Blended Vaporization BV 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 NOTE Power can only be adjusted with the G...

Страница 16: ...E 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 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 ...

Страница 17: ...ed 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 simultaneously can reset the Generator for fault conditions System Description 4 5 v bv pedal yellow desiccate pedal blue FOOTSWITCH CONNECTOR FOOTSWITCH CABLE FIGURE 4a ...

Страница 18: ...ay be controlled as follows Depressing and releasing the menu reset button when the VAPR Generator is waiting for user interaction ready state will initiate a setting adjustment procedure 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 the left of display as shown in FIGURE 5a While the power se...

Страница 19: ...d time hold for 2 beeps high low release Ablation Mode V3 V2 V1 BV2 BV1 Press menu button third time hold for 2 beeps same tone low release Desiccation Power Press menu button fourth time hold for 2 beeps low high release Operative Mode Ablation Desiccation 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 ...

Страница 20: ...he tip and helps minimize clogging LDS LPS and VAPR S90 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...

Страница 21: ...ue 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 i...

Страница 22: ...ce 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 Connector plug Connector cable handpiece working tip electrode shaft electrode connector FIGURE 6 System Description 4 10 ...

Страница 23: ...m 225213 VAPR 2 3 Wedge Electrode Short 85 mm 225203 VAPR 2 3 Wedge Electrode 140 mm 225312 VAPR Flexible Side Effect Electrode 3 5 mm x 160 mm 225314 VAPR Flexible End Effect Electrode 3 5 mm x 160 mm 227301 VAPR Side Effect Electrode 3 5 mm Side Effect with Integrated Handpiece 227305 VAPR Hook Electrode 3 5 mm Hook with Integrated Handpiece 227302 VAPR Angled Side Effect Electrode with Integrat...

Страница 24: ...ion with Integrated Handpiece 227204 VAPR Premiere90 Electrode 90 Suction with Integrated Handpiece 227252 VAPR Temperature Control End Effect Electrode with Integrated Handpiece 2 3 mm x 140 mm 225252 VAPR Temperature Control End Effect Electrode 2 3 mm x 140 mm WARNING Read the instructions cautions and warnings provided with all VAPR 3 System accessories before use This device is an integral sy...

Страница 25: ...andard cart system Ensure adequate ventilation as it is normal for the Generator to become warm during use WARNING Ensure that the generator is positioned so that the ability to disconnect or isolate from the mains supply is not restricted To avoid the risk of electric shock this equipment must only be connected to a supply main with protective earth CAUTION EMC CONSIDERATIONS Provide as much sepa...

Страница 26: ...es When the Generator is first switched on prior to Electrode connection a system self check sequence will be initiated 7 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 II ONLY VAPR II System Component Requir...

Страница 27: ...ctrode 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 D...

Страница 28: ... in temperature control mode an audible tone will sound if the measured TIP temperature reaches more than 8ºC 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...

Страница 29: ...ge 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 patien...

Страница 30: ...after device activation ablation The pinch 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 y...

Страница 31: ...d 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 residual cleansing agents with a damp cloth 5 Dry the accessory devices thoroughly b...

Страница 32: ... 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 repo...

Страница 33: ...hich 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 Generato...

Страница 34: ...y 500Hz for 110mS repeated while condition occurs Non Thermistor Electrode Alarm Description Short 65ms at 800Hz followed by 65ms at 500Hz while condition occurs and pedal pressed Fault Symbol Ref Description 100 10 Software failure 100 11 ROM checksum failure 100 12 Non volatile memory failure 100 13 Memory failure 100 14 Power generation fault on start up 100 15 Power generation shutdown fault 2...

Страница 35: ...n stuck on 400 14 Electrode identification circuit fault 400 15 Front panel yellow UP button stuck on 400 16 Front panel yellow DOWN button stuck on 400 17 Front panel blue UP button stuck on 400 18 Front panel blue DOWN button stuck on 400 19 Front panel MODE button stuck on 400 20 Reserved for Intermittent activation switch 400 21 Electrode thermistor open circuit bands 11 13 400 22 Electrode th...

Страница 36: ...e if problem persists Generator displays CONNECT CABLE symbol when Handpiece Cable is inserted Remove connector and inspect pins for damage Check that connector is fully inserted Check for damage to Cable Generator displays INSERT ELECTRODE symbol after Electrode is inserted Ensure the connector contacts are clean and dry and have not been damaged during reprocessing Check Electrode integrity Ensu...

Страница 37: ...rator mode buttons to restore the system to its ready condition Check the accessories by activating the electrode 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 hand piece and check as above Do not use any accessory that persist...

Страница 38: ... 9 cm x 41 cm x 36 8 cm Weight 12 lb 5 6kg approximately Transport and Storage Conditions Ambient Temperature Range 32 to 122 F 0 to 50 C 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 Regulatio...

Страница 39: ...Rating IPX8 OUTPUT WAVEFORM AND CHARACTERISTICS VAPR II 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 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 ...

Страница 40: ...siccate at Half Power 60W V3 V2 V1 DES Half Power 100W Load Curve Load Ohms Note 1 Desiccate Full Power 120W 3A Limit prevents 10R measurement Note 2 Internal Limiting 10R Output V3 V2 V1 DES Full Power 200W Load Curve VAPR II ONLY VAPR II ONLY VAPR II ONLY ...

Страница 41: ...imum 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...

Страница 42: ...ower 260W Load Curve LOAD CURVE 240 a c RF POWER OUTPUT 260W DES 120W POWER LINEARITY 160 ohm v3 VAPR 3 ONLY VAPR 3 ONLY LOAD CURVE 240v a c RF POWER OUTPUT 130W DES 60W Half Power 130W Load Curve VAPR 3 ONLY V3 V2 V1 DES V3 V2 V1 DES W ...

Страница 43: ...hod layout depicted in FIGURE 5 2 This is the scheme adopted by DePuy Mitek for all product manufacture tests and has been found to be in accordance with the power measurement strategy for electrosurgical equipment employed by certified test agencies Attempting to obtain an output power measurement by direct measure of voltage may give results that are inaccurate and unrepresentative of the system...

Страница 44: ...d by DePuy Mitek Products Inc Attempting to fashion a good electrical contact between the two poles of the small geometry electrode tip is fraught with difficulties and can lead to misleading results Technical Specifications A 7 FOOCTSWITCH VAPR GENERATOR OUTPUT TEST CABLE RF VOLTMETER NON INDUCTIVE LOAD CURRENT MONITOR ...

Страница 45: ... provides a degree of protection against 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 This symbol indicates that the product contains less than the max...

Страница 46: ...ir Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical Fast Transient Burst IEC 61000 4 4 2 kV for Power Supply Lines 1 kV for Input Output Lines 2 kV for Power Supply Lines 1 kV for Input Output Lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5...

Страница 47: ...ers as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 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 ...

Страница 48: ...to 800 MHz d 3 5 E1 P 800 MHz to 2 5 GHz d 7 E1 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 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 trans...

Страница 49: ...dited service replacement program for its products to minimize downtime in your operating room For a return authorization number or for additional information on this program call DePuy Mitek Customer Service at 1 800 382 4682 and choose Option 2 in the United States or contact your DePuy Mitek representative Warranty and Service DePuy International Ltd St Anthony s Road Leeds LS11 8DT England Tel...

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