Mitek VAPR II User Manual
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Mitek VAPR II User Manual

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User Manual

English
P/N: 103097
GYRUS P/N:
Rev: N Revised 11/2014
126063-HC
© 2004-2014 DePuy Mitek

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Summary of Contents for Mitek VAPR II

  • Page 1: User Manual

    User Manual English P/N: 103097 GYRUS P/N: Rev: N Revised 11/2014 126063-HC © 2004-2014 DePuy Mitek...
  • Page 2 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 relevant copyright laws. Do not reproduce any portion of this manual, in any form, without express written approval of DePuy Mitek.
  • Page 3 This manual covers both the VAPR II and VAPR 3 System. Except where otherwise indicated, the instructions for use apply to both systems.

  • Page 4: Table Of Contents

    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...

  • Page 5: Ntroduction

    NtRodUCtIoN combination of instruments during an arthroscopic procedure. The DePuy 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.

  • Page 6: 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 DePuy Mitek VAPR System (FIGURE 1) are individually described in Section 4 of this manual: •...

  • Page 7: Principle Of Operation

    PRINCIPLE OF OPERATION The VAPR System offers four bipolar modes of operation: Vaporization, Desiccation, Blended Vaporization and desiccation with temperature indication. • In 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.

  • Page 8: Ndications For U Se , C Ontraindications

    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:...

  • Page 9: Afety

    Section 3 AFety 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 and is for use only by licensed physicians, trained in the use of this device.

  • Page 10: Emc Precautions

    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 requirements for safe grounding. Do not use extension cords, multiple point plugs or 2 to 3 pronged adapters.

  • Page 11: During Surgery

    DURING SURGERY NOTE For the purposes of safety procedures, and despite the absence of a conventional return pad, the VAPR System should still be treated as a high power electrosurgical device. WARNING Failure of the HF surgical equipment could result in an unintended increase or decrease in output power, change in output waveform characteristics or absence of electrosurgical output.

  • Page 12: After Surgery

    • 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 is depressed, indicating the electrode is activated. • If possible, avoid the use of needle style electrodes for any physiological monitoring equipment that may be connected to the patient during electro-surgery.

  • Page 13: System D Escription

    Section 4 ystem escrIptIon VAPR GENERATOR The VAPR 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 activated using...
  • Page 14 4 pin v/bv power desiccate power up/down adjustment, SET up/down adjustment and TEMPERATURE UP/ mode selector 3 pin 4 pin DOWN ADJUSTMENT VAPR II only VAPR 3 only YStem eSCRIPtIoN EQUALIZATION TERMINAL AC POWER INPUT heat sink fuse holder fIGURe 3...

  • Page 15: Generator Controls And Displays

    GENERATOR CONTROLS AND DISPLAYS 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.

  • Page 16: Front Panel Display Symbols

    OUTPUT (YEL) Indicates that the output mode for yellow pedal activation can be selected. FOOTSWITCH VAPR II ONLY 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 volume available, “MAX”...

  • Page 17: Footswitch

    FOOTSWITCH (VAPR II ONLY) The 2 pedal Footswitch (FIGURE 4 ) 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.
  • Page 18 FOOTSWITCH (VAPR 3 ONLY) The VAPR 3 Footswitch (FIGURE 4 ) 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). •...
  • Page 19 Menu Button Modify Yellow Pedal Blue Pedal Press menu button once, hold for 2 beeps Ablation Power (same tone-high), release. Press menu button second time, hold for Ablation Mode 2 beeps (high-low), release. (V3, V2, V1, BV2, BV1) Press menu button third time, hold for Desiccation Power 2 beeps (same tone-low), release.

  • Page 20: Vapr Electrodes

    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”...
  • Page 21 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.

  • Page 22: Vapr Handpiece And Cable

    VAPR HANDPIECE AND CABLE The VAPR Handpiece/Electrode (FIGURE 6) 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.
  • Page 23 Part Number Product Description VAPR ® Handpiece 225002 REUSABLE VAPR ® 3 Footswitch 225023 REUSABLE VAPR ® End Effect Electrode 225303 3.5 mm x 160 mm VAPR ® Side Effect Electrode 225301 3.5 mm x 160 mm VAPR ® 90 Degree Hook Electrode 225305 3.5 mm x 160 mm VAPR ®...
  • Page 24 VAPR ® 2.3 End Effect Electrode (Short) 227202 with Integrated Handpiece, 140 mm VAPR ® LD Suction Electrode 225360 4.0 mm x 160 mm VAPR ® LP Suction Electrode 225361 4.0 mm x 160 mm VAPR ® S90 Electrode 225370 4.0 mm, 90°...

  • Page 25: Instructions For U Se

    • The equipment is used in accordance with these instructions. The DePuy Mitek VAPR System unit has been designed as a system, with accessory features NStRUCtIoNS specifically designed to maximize safety and effectiveness. Use only the DePuy Mitek Handpiece and Electrodes with this System.

  • Page 26: System Setup And Use During Surgery

    SYSTEM SETUP AND USE DURING SURGERY VAPR II ONLY VAPR II System Component Requirements: • A properly installed VAPR II Generator with attached 2 pedal Footswitch • A Sterile VAPR Handpiece and Cable or VAPR Electrode with Integrated Handpiece •...
  • Page 27 BLUE PEDAL: Activates the Desiccate (DES) mode only. Activation is accompanied by flashing of the Desiccate power display and an audible tone. 8. (VAPR II 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.

  • Page 28: Using Vapr Tc Electrodes

    The vaporization output is inhibited, pressing the yellow pedal will have no effect. • (VAPR 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’.

  • Page 29: Changing Electrodes During Surgery

    • 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. •...

  • Page 30: Use Of Suction Electrodes

    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 Suction electrodes are designed to provide improved visibility at the operative site whilst facili- tating removal of degradation products.

  • Page 31: Leaning And S Terilization P Rocedures

    (e.g. crush damage, cracking, or distortion). Discard if damage is observed. WARNING The DePuy 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...

  • Page 32: Eriodic Aintenance Nspection

    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 DePuy Mitek customer service should a unit fault be suspected.

  • Page 33: Rror And Sg

    An Error symbol indicates an accessory malfunction or a Generator component failure that requires servicing of the equipment. These symbols include a code number to be RRoR aNd used by DePuy Mitek technical service to diagnose why the system failed. aUlt YmbolS •...
  • Page 34 If this does not resolve the problem, contact DePuy Mitek customer service. A list of all Fault symbols and their descriptions is provided below: There are no user defined alarms used in the VAPR system. There are no distributed alarms used in the VAPR system.
  • Page 35 Temperature monitor inoperative Audio volume inoperative Diagnostic circuit fault CURRLIM signal error Electrode temperature measurement malfunction Internal overheating Excess RF input voltage error Out of specification input voltage : low Out of specification input voltage : high Bipolar output short circuit Unable to control electrode temperature Unsupported electrode attached Footswitch BLUE pedal stuck on...

  • Page 36: Troubleshooting Guide

    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 DePuy Mitek Customer Service.
  • Page 37 UIde Do not use any accessory that persistently faults. If the fault continues, contact DePuy 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.
  • Page 38 90 – 132V RMS, 198 – 264V RMS Operating Range: nominal 100 – 120/220 – 240V RMS 50/60Hz Inlet Fuses: Time lag 5A (T5AH 250V) (VAPR II ONLY) Inlet Fuses: Time lag 6.3A (T6A3H 250V) (VAPR 3 ONLY) Leakage Currents:...
  • Page 39 >8ºC above SET temperature VaPR footSWItCH SPeCIfICatIoNS Cat. . 225003 & 225023 Rating IPX8 OUTPUT WAVEFORM AND CHARACTERISTICS (VAPR II ONLY) Waveform The RF output is a variable amplitude sinusoid eCHNICal waveform varying between approximately PeCIfICatIoNS 340kHz and 450kHz, corresponding to minimum and maximum load impedance respectively.
  • Page 40 VAPR II ONLY (V3) into 160 ohm load VAPR II ONLY (100W) l oWeR URVe eCHNICal PeCIfICatIoNS Desiccate at Half Power 60W VAPR II ONLY (200W) l oWeR URVe Note (1): Desiccate Full Power 120W Load/Ohms 3A Limit prevents 10R measurement...
  • Page 41 VAPR II AND VAPR 3 OUTPUT WAVEFORM AND CHARACTERISTICS (VAPR 3 ONLY) eCHNICal PeCIfICatIoNS 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.
  • Page 42 VAPR 3 ONLY (130W) l oWeR URVe load CURVe (240 ) Rf PoWeR oUtPUt 130W (deS 60W) eCHNICal VAPR 3 ONLY PeCIfICatIoNS (260W) l oWeR URVe load CURVe (240 ) Rf PoWeR oUtPUt 260W (deS 120W) VAPR 3 ONLY PoWeR lINeaRItY (160...
  • Page 43 Technical support in connection with end user corroboration of the published VAPR generator load curves can only be provided by DePuy Mitek on the condition that the user’s eCHNICal measurement system corresponds to the test method layout depicted in FIGURE 5.2. This is...
  • Page 44 CAUTION The practice of using an electrode as the power measurement connection medium is actively discouraged by DePuy Mitek Products Inc. Attempting to fashion a good electrical contact eCHNICal between the two poles of the small geometry electrode tip is fraught with difficulties and can PeCIfICatIoNS lead to misleading results.
  • Page 45 Equipment fault Refer to instruction manual/booklet Refer to instruction manual/booklet eCHNICal PeCIfICatIoNS Non-ionizing radiation. This equipment intentionally emits RF energy during activation. Defibrillator-proof type BF equipment. This equipment 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.
  • Page 46 Appendix B EMC T ablE uidance 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.
  • Page 47 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 Test Compliance Level Electromagnetic Environment -...
  • Page 48 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 GENERATOR 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.
  • Page 49 ArrAnty And ervIce DePuy Mitek products are guaranteed to be free from defects in material and workmanship for the warranty period of a particular product, beginning from date of invoice. Contact your DePuy Mitek representative for specific product warranty information.

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