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Arthrex DualWave User Manual

Arthroscopy pump
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DFU-0212, Rev. 1
English
DualWave™ Arthroscopy Pump
User's Guide
The Arthrex DualWave™ Arthroscopy Pump User's Guide provides safety operation information
for all components of the Arthrex DualWave Arthroscopy Pump (model AR-6480), including
accessories. All operating personnel must read this User's Guide for version 1.7 or higher
thoroughly prior to using this system and follow all safety warnings, cautions, and precautions.
U.S. PATENTS No. 5,520,638 and 8,206,342
0086
Arthrex, Inc.
1370 Creekside Blvd.
Naples, FL 34108-1945 USA
Toll Free: 1-(800) 934-4404
www.arthrex.com
Arthrex GmbH
Erwin-Hielscher-Strasse 9
81249 München, Germany
Tel: +49 89 909005-0
www.arthrex.de
DFU-0212
Revision 1
© 2015 Arthrex, Inc. All rights reserved

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  • Page 1 User’s Guide The Arthrex DualWave™ Arthroscopy Pump User’s Guide provides safety operation information for all components of the Arthrex DualWave Arthroscopy Pump (model AR-6480), including accessories. All operating personnel must read this User’s Guide for version 1.7 or higher thoroughly prior to using this system and follow all safety warnings, cautions, and precautions.
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  • Page 3: Table Of Contents

    Table of contents 1.0 General Warnings and Safety Notices - Read This First ..... 1 Important Safety Conventions ................1 Symbols Definition ..................... 4 Shipping, Unpacking, and Warranty Information ..........6 0 Product Description ................7 Product Description and Intended Use ............... 7 Product Features ....................
  • Page 4 Table of contents Electromagnetic Compatibility (EMC) ............... 25 Basic Setup Procedure for the AR-6480 ............25 Shaver Detect ....................27 Shaver Detect, Synergy System Connection ............27 Shaver Detect, Shaver Power Cable ..............27 Shaver Detect, Inflow only ...................28 Shaver Detect, Inflow/Outflow ................28 Adjusting the Shaver Detect .................29 How to Set Up the Synergy Heads-Up Display ..........
  • Page 5 Table of contents Transmissible Spongiform Encephalopathy Agents ......... 41 0 Maintenance ..................42 Periodic Maintenance ..................42 0 Technical Support................43 How to Display the Software Version ............... 43 Additional Technical Information ..............43 Troubleshooting ................44 10.1 Troubleshooting Interference with Other Devices ......... 45 Repair Policy ........
  • Page 6 This is not a warranty document. For all warranty information, including disclaimers, exclusions, terms, conditions and related provisions, refer to the "Arthrex U.S. Product Warranty" section of the Arthrex, Inc. website, found at www.arthrex.com whose provisions are incorporated herein by reference.

  • Page 7: General Warnings And Safety Notices - Read This First

    3. Failure to adhere to the setup instructions and use of Arthrex certified tubing may result in inaccurate pressure sensing and monitoring by the device. It is imperative that the user is aware that patient safety may be compromised when an alarm on the pump is ignored or silenced incorrectly.
  • Page 8 11. Use only Arthrex approved accessories. Other accessories may result in increased emissions or decreased immunity of the system. Contact your Arthrex representative for a complete list of accessories. DO NOT modify any accessory. Failure to comply may result in injury to the patient and/or operating room staff.
  • Page 9 EMC compatibility. This device may cause interference with other devices in the near vicinity if not set up and used as instructed by Arthrex. 8. Do not attach the remote control or the foot pedal during the Self Test or Programming Modes.

  • Page 10: Symbols Definition

    14. Refer to the Instructions for Use package insert (DFU-0144) for detailed remote control cleaning and sterilization instructions included with each remote control. Additional copies of this insert can be obtained from the Arthrex website at www.arthrex.com, or by contacting your local Arthrex representative.
  • Page 11 General Warnings and Safety Notices - Read This First DualWave Arthroscopy Pump User’s Guide Electrical hazard, dangerous voltages are present. Never attempt to repair the equipment. Only Temperature limits for trained service storage and transport personnel may remove the cover, or obtain access to system components.

  • Page 12: Shipping, Unpacking, And Warranty Information

    Refer also to our General Terms of Business. All defective products will be repaired or replaced at the discretion of Arthrex at no charge. The warranty does not cover damage caused by unlawful use or improper handling of a product.

  • Page 13: Product Description

    USE THE PUMP WITHOUT RESOLVING AN ALARM CONDITION COULD RESULT IN A SERIOUS PATIENT ADVERSE EVENT. Failure to adhere to the setup instructions and use of Arthrex certified tubing may result in inaccurate pressure sensing and monitoring by the device. It is imperative that the user is aware that patient safety may be compromised when an alarm on the pump is ignored or silenced incorrectly.
  • Page 14 The pump tubing can be reused for an entire surgical day. The patient tubing must be replaced after each surgical procedure. Outflow tubing. When the Outflow Tubing Set is attached to the AR-6480, the DualWave Arthroscopy Pump changes from an inflow-only pump to an inflow/outflow fluid management system.

  • Page 15: Product Features

    Product Description DualWave Arthroscopy Pump User’s Guide Product Features AR-6480 Console: Front View Figure 1 uses a numeric callout system to identify the main elements of the console’s front panel, which are listed and labeled in Table 1. These callouts are referenced throughout this User’s Guide.

  • Page 16: Ar-6480 Console: Rear View

    AC mains power input plug Shaver Detect power socket Address Void seal sticker USB port (For use ONLY with an Arthrex approved thumb drive) Serial ports for Arthrex integration (refer to IFU 950-0052-00) Access panel (for Arthrex authorized use only) Serial number label...

  • Page 17: Ar-6480 Operator Display Messages And Iconography

    Product Description DualWave Arthroscopy Pump User’s Guide AR-6480 Operator Display Messages and Iconography The console’s operator display [5] provides information about the status of the AR- 6480 modes, pressure, and flow settings in real time. Table 3 describes each message or button, cause and explanation when the pump is in the ready state.
  • Page 18 Product Description DualWave Arthroscopy Pump User’s Guide Message Cause Explanation − Button Pressure set decrease. The operator display shows the pressure reading until the PRESSURE (-) button is pressed. Once pressed, the displayed pressure reading will change to the pressure setting. Each subsequent press of the pressure button will decrease the pressure setting in increments of 5.

  • Page 19: Foot Pedal Unit (Ar-6483)

    DualWave Arthroscopy Pump User’s Guide Foot Pedal Unit (AR-6483) The AR-6480 DualWave Arthroscopy Pump can be remotely controlled with the optional foot pedal unit (AR-6483). It provides a Lavage function and a Rinse function. See Figure 3 and Table 4.

  • Page 20: Remote Control Unit (Ar-6482)

    DualWave Arthroscopy Pump User’s Guide Remote Control Unit (AR-6482) The AR-6480 DualWave Arthroscopy Pump can be remotely controlled with the optional, autoclavable remote control unit (AR-6482). It provides the ability to control pressure adjustments; a Lavage function; a Rinse function; shaver suction controls;...

  • Page 21: Tubing

    Product Description DualWave Arthroscopy Pump User’s Guide Tubing Tubing Configurations Figure 5, Figure 6, and Figure 7 show the tubing combinations supported by the AR-6480. Figure 5 One-Piece Tubing Configuration Table 6 Elements of the One-Piece Tubing Configuration Element Description...

  • Page 22: Figure 6 Two-Piece Tubing Configuration

    Product Description DualWave Arthroscopy Pump User’s Guide Figure 6 Two-Piece Tubing Configuration Table 7 Elements of the Two-Piece Tubing Configuration Element Description Tubing Set Bag spikes AR-6215 Tubing clamps AR-6215 AR-6411/AR-6420 AR-6421/AR-6425 Green connector AR-6411/AR-6420 Tubing boot AR-6411/AR-6420 Pressure line connector...

  • Page 23: Main Pump Tubing Set (Ar-6410: Region A)

    This User’s Guide assumes that the AR-6410 is used alone or in combination with the AR-6220, described below. For specific information about each tubing set, refer to the Directions for Use that are included with each set or contact your Arthrex representative. DFU-0212 Rev. 1 Page 17 of 54...

  • Page 24: Redeuce™ Pump Tubing Set (Ar-6411: Region A)

    Product Description DualWave Arthroscopy Pump User’s Guide ReDeuce™ Pump Tubing Set (AR-6411: Region A) The ReDeuce Pump Tubing Set is intended to be used in conjunction with the ReDeuce Patient Tubing Set (AR-6421) to offer inflow and pressure sensing tubing. It is not intended to be used as a stand-alone product. The ReDeuce Pump Tubing Set may be used for an entire surgical day, unless sterility is compromised in any way.

  • Page 25: Patient Extension Tubing System (Ar-6425: Region B)

    Outflow Pump Tubing Set (AR-6430) The Outflow Pump Tubing is intended to be used with all the Arthrex tubing sets while in inflow/outflow mode to provide precisely-controlled outflow from the shaver and a cannula (optional) to multiple waste consumption devices.

  • Page 26: Table 9 Tubing Set Correlation And Comparisons

    Product Description DualWave Arthroscopy Pump User’s Guide Table 9 Tubing Set Correlation and Comparisons Region A Region A Region B Region B Tubing Set Tubing Set Tubing Set Tubing Set Part Number Description Part Number Description AR-6410 Main Pump Tubing Set...

  • Page 27: Technical Specifications

    Technical Specifications DualWave Arthroscopy Pump User’s Guide 0 Technical Specifications Console Table 10 Control Unit (AR-6480) Specifications Width 42 cm (16.5 in.) Height 19 cm (7.5 in.) Depth 35.5 cm (14 in.) Weight 12.25 kg (27 lbs.) Maximum flow rate ≥...

  • Page 28: Foot Pedal

    Surface cleaning with mild detergent Sterilization Autoclave Safety, EMC, and Regulatory Requirements The DualWave Arthroscopy Pump (AR-6480) is designed and tested in accordance with: EN 60601-1/A2:1995 UL 60601-1:2003 CAN/CSA-C22.2 No. 601.1-M90 According to 60601 this device is Type CF, Class 1, IP22 rating.

  • Page 29: Setup

    This power supply allows users to connect the console to any local AC mains outlet. Please use the appropriate plug and a reliable ground conductor. Arthrex supplies separate power cords for the U.S. and Europe CEE 7/7 with the AR-6480. Contact your Arthrex representative if you need a power cord that must meet the electrical standards of another country.

  • Page 30: Replacing The Fuses

    Setup DualWave Arthroscopy Pump User’s Guide In the event of an AC power interruption, the console can run continuously without fault for up to 10 milliseconds. If an AC power failure lasts longer than 10 milliseconds, the system will reset to the default settings when the AC power is restored.

  • Page 31: Electromagnetic Compatibility (Emc)

    Section 5.0, Operation, explains how to use the console. Place the AR-6480 on a flat, dry surface in the same horizontal plane as the operative site, such as the AR-6481 Arthrex Arthroscopy pump cart. Connect the receiver end of the power cord for the AR-6480 into the AC mains power socket [14] and the plug end to the facility AC mains supply.
  • Page 32 W A R N I N G ! Use ONLY Arthrex approved accessories. Other accessories may result in increased emissions or decreased immunity of the system. Contact your Arthrex representative for a complete list of accessories. DO NOT modify any accessory.

  • Page 33: Shaver Detect

    Detect feature operates differently, depending on if an AR-6430 Outflow Tube Set is installed on the DualWave. Shaver Detect can be set up in three different ways. NOTE: The Shaver Detect feature will function as described in sections 4.6.3 – 4.6.4.

  • Page 34: Shaver Detect, Inflow Only

    Shaver Detect, Inflow only During inflow only (no outflow tube set) when the shaver is activated the DualWave activates BOOST mode for increased pressure to compensate for the loss of distention from the vacuum used with the shaving device. The pressure will automatically change to the preset BOOST values, and can be noted on the operator display [5].

  • Page 35: Adjusting The Shaver Detect

    • prevent false detections of shaver activation. This condition makes the DualWave behave as if the shaver handpiece is activated when it is not. This is characterized by sporadic movement of the pinch roller between the Shaver DFU-0212 Rev. 1...

  • Page 36: How To Set Up The Synergy Heads-Up Display

    DualWave to provide for aspiration through the shaver blade and result in retention of heat within the blade. As the DELAY value decreases the DualWave will have less time to analyze the • information received through the Shaver Detect circuit. This action can result in a false detection.

  • Page 37: How To Set Up The Two-Piece Tubing System

    Setup DualWave Arthroscopy Pump User’s Guide NOTE: The inflow door locking device must be secure. If the door is not closed securely an internal safety switch prevents the AR-6480 from operating. Puncture the fluid bags with the spikes on the tubing. If only one fluid bag is being used, seal the second fluid line by closing the clamp nearest to the unused spike.

  • Page 38: How To Change The Language Setting

    10.0 for troubleshooting information. NOTE: If abnormal console operation cannot be corrected, disinfect the pump, repackage in the original shipping materials, and return to Arthrex, accompanied by a brief description of the malfunction. Prior to shipping, it is necessary to obtain a return authorization number from Arthrex.

  • Page 39: Tubing Sensor Coupler

    Setup DualWave Arthroscopy Pump User’s Guide 4 Tubing Sensor Coupler The pump motor automatically deactivates when the tubing is disconnected from the pump. If the tubing is disconnected during a surgical procedure it must be replaced by new tubing. Do not reconnect the tubing to the pump as it could lead to unreliable pressure.

  • Page 40: Operation And Frequently Used Functions

    Operation and Frequently Used Functions DualWave Arthroscopy Pump User’s Guide 0 Operation and Frequently Used Functions Users of this device should contact their Arthrex representative if they require a more comprehensive surgical technique. Initial Pressure Settings W A R N I N G ! The safety and effectiveness of the AR-6480 is verified and documented;...

  • Page 41: How To Operate The Ar-6480 In Inflow Only Mode

    Operation and Frequently Used Functions DualWave Arthroscopy Pump User’s Guide W A R N I N G ! The initial pressure settings are recommendations. It is always appropriate and prudent to use the lowest possible pressure setting to minimize extravasation and any other pressure-related injury to the patient.

  • Page 42: How To Operate The Ar-6480 In Inflow/Outflow Mode

    Operation and Frequently Used Functions DualWave Arthroscopy Pump User’s Guide How to Operate the AR-6480 in INFLOW/OUTFLOW Mode W A R N I N G ! The extension, patient, and/or outflow tubing must be replaced before each new patient and/or procedure.

  • Page 43: How To Operate The Ar-6480 In Rinse Mode

    Operation and Frequently Used Functions DualWave Arthroscopy Pump User’s Guide How to Operate the AR-6480 in RINSE Mode The AR-6480 pump has a RINSE function for irrigation purposes. The RINSE MODE is only accessible in INFLOW/OUTFLOW MODE. Press the RINSE button [Table 3, ii or IV] to enable this function. The RINSE button should turn color and begin a countdown.

  • Page 44: Cleaning And Disinfecting

    Additional copies of this insert can be obtained from the Arthrex website at www.arthrex.com, or by contacting your local Arthrex representative. The remote control unit (AR-6482) is supplied non-sterile.

  • Page 45: Foot Pedal Control Unit (Ar-6483)

    Cleaning and Disinfecting DualWave Arthroscopy Pump User’s Guide NEVER allow the console receptacles to have any contact with liquids. If there is dust or moisture on the receptacles, remove using dry compressed air. ONLY dry connectors should be plugged into the console.

  • Page 46: Tubing

    Additional copies of this insert can be obtained from the Arthrex website at www.arthrex.com, or by contacting your local Arthrex representative. W A R N I N G ! The extension, patient, and/or outflow tubing must be replaced before each new patient and/or procedure.

  • Page 47: Sterilization

    Additional copies of this insert can be obtained from the Arthrex website at www.arthrex.com, or by contacting your local Arthrex representative. After sterilization in the autoclave, let the accessory device cool down slowly.

  • Page 48: Maintenance

    Maintenance DualWave Arthroscopy Pump User’s Guide 0 Maintenance Regular and proper maintenance of your DualWave Arthroscopy Pump is the best way to protect your investment and avoid non-warranty repairs. Recommended care and handling of the DualWave Arthroscopy Pump includes proper day-to-day operation, cleaning, and sterilization which are extremely important to ensure safe and efficient operation.

  • Page 49: Technical Support

    DualWave Arthroscopy Pump User’s Guide 0 Technical Support For assistance in using the products identified in this User’s Guide, contact an Arthrex representative or contact the Arthrex Technical Support Hotline at 1-(888) 420-9393, Monday through Friday from 9:00 AM to 5:00 PM EST; or at +49 89 90 90 05 8800 techsupport@arthrex.de...

  • Page 50: Troubleshooting

    ** Critical Failure ** Roller housing is not secured – ensure the locking lever is properly secured. ** Door Open ** If the failure persists, return to Arthrex for repair. Increase or open the outflow. ** Overpressure ** Manipulate the joint to a stress-free position.

  • Page 51: Troubleshooting Interference With Other Devices

    Isolate the power source. If the failure persists, return to Arthrex for repair. If the problems persist, disinfect the DualWave Arthroscopy Pump and send to Arthrex using the original packaging. Always send the corresponding console together with the tubing, foot pedal, and remote control. Please enclose a brief explanation of the detected malfunction.

  • Page 52: Repair Policy

    Repair Policy DualWave Arthroscopy Pump User’s Guide 0 Repair Policy Contact Arthrex for a return authorization number and instructions prior to returning the device. DFU-0212 Rev. 1 Page 46 of 54...

  • Page 53: End Of Life, Environmental Directives

    For more information about where you can drop off your medical electronic equipment at the end of its useful life for recycling, please contact Arthrex Customer Service Department.

  • Page 54: Electromagnetic Emissions

    Table 17 Guidance and Manufacturer's Declaration - Electromagnetic Emissions The AR-6480 DualWave Arthroscopy Pump is intended for use in the electromagnetic environment specified below. The customer or the user of the AR-6480 DualWave Arthroscopy Pump should ensure that it is used in such an environment.

  • Page 55: Table 19 Guidance And Manufacturer's Statement - Electromagnetic Immunity

    Table 19 Guidance and Manufacturer's Statement - Electromagnetic Immunity The AR-6480 DualWave Arthroscopy Pump is intended for use in the electromagnetic environment specified below. The customer or the user of the AR-6480 DualWave Arthroscopy Pump should ensure that it is used in such an environment.

  • Page 56: Table 20 Guidance And Manufacturer's Statement - Electromagnetic Immunity (Cont'd)

    Guidance and Manufacturer's Statement - Electromagnetic Immunity (cont’d) The AR-6480 DualWave Arthroscopy Pump is intended for use in the electromagnetic environment specified below. The customer or the user of the AR-6480 DualWave Arthroscopy Pump should ensure that it is used in such an environment.
  • Page 57 Electromagnetic Emissions DualWave Arthroscopy Pump User’s Guide Immunity IEC 60601 Compliance Electromagnetic environment - guidance test test level level b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. DFU-0212 Rev. 1...
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  • Page 60 Arthrex, Inc. 1370 Creekside Blvd. Naples, FL 34108-1945 USA www.arthrex.com Customer Service 1-(800) 934-4404 Toll-Free Technical Support: 1-(888) 420-9393, Monday through Friday, 9:00 AM – 5:00 PM EST. Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany Tel: +49 89 909005-0 www.arthrex.de All rights reserved.

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