Arthrex AR-6480 User Manual
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Arthrex AR-6480 User Manual

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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
thoroughly prior to using this system and follow all safety
warnings, cautions, and precautions.
U.S. PATENT No. 5,520,638
0086
Arthrex, Inc.
Naples, FL 34108-1945 USA
Toll Free: 800 934-4404
www.arthrex.com
Arthrex Med. Inst. GmbH
85757 Karlsfeld, Germany
Telephone: 49 81 31 59 57 290
www.arthrex.de
LM1-0630-EN_E
© 2012 Arthrex, Inc. All rights reserved.

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  • Page 1 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 thoroughly prior to using this system and follow all safety warnings, cautions, and precautions.

  • Page 3: Table Of Contents

    How to Set Up the Console ................18 AC Power Safety Considerations ..............18 Replacing the Fuses ..................19 Electromagnetic Compatibility ................19 Basic Setup Procedure for the AR-6480 ............19 Shaver Detection ....................20 4.6.1 Shaver Detect, Inflow only ...................20...
  • Page 4 Tubing Sensor Coupler ..................25 Operation .................... 26 Initial Pressure Settings..................26 How to Operate the AR-6480 in INFLOW ONLY Mode ........27 How to Operate the AR-6480 in INFLOW/OUTFLOW Mode......28 How to Operate the AR-6480 in LAVAGE Mode ..........28 How to Operate the AR-6480 in RINSE Mode ..........
  • Page 5 Table of contents 12.0 Limited Warranty ................38 13.0 Repair Policy ..................39 14.0 Electromagnetic Emissions .............. 40 15.0 Contact Information................43 15.1 Compliance Information ................43 LM1-0630-EN_E Page iii of 43...
  • Page 6 Elements of the ReDeuce Tubing Configuration ............13 Table 8 Elements of the Outflow Tubing Configuration ............14 Table 9 Control Unit (AR-6480) Specifications ................16 Table 10 Ambient conditions for operation .................. 16 Table 11 Ambient conditions for storage (in shipping packaging)..........16 Table 12 Foot Pedal Unit (AR-6483) Specifications ..............

  • Page 7: 1.0 Read This First

    USE THE PUMP WITHOUT RESOLVING AN ALARM CONDITION COULD RESULT IN A SERIOUS PATIENT ADVERSE EVENT. Failure to adhere to the set up 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 of the potential compromise in patient safety when an alarm on the pump is ignored or silenced incorrectly.

  • Page 8: Important Symbols And Conventions

    Read this User’s Guide thoroughly before operating the device and NOTE: save it for future reference. Users of this device are encouraged to contact their Arthrex representatives if they require a more comprehensive surgical technique. Important Symbols and Conventions It is imperative that the symbols and conventions listed below be clearly understood.
  • Page 9 Square brackets that enclose a letter, number or lower-case Roman numeral reference a callout on a line drawing. Section 2.2, Product Features, includes line drawings of all products associated with the AR-6480. Each line drawing has its own callout system to identify important elements of each product. LM1-0630-EN_E...

  • Page 10: Shipping, Unpacking And Warranty Information

    A 12 month warranty is provided to the first purchaser for any defects or failure of the medical devices. 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 11: Product Description

    The optional Y-Tubing connects up to four irrigation bags and can be used with all AR-6480 pump tubing options. The AR-6480 can be used as an inflow-only irrigation pump or, with the Outflow Tubing attached; it can be used as an inflow/outflow fluid management system.

  • Page 12: Product Features

    DualWave Arthroscopy Pump User’s Guide Product Features 2.2.1 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 13: Ar-6480 Console: Rear View

    Table 2 Rear Panel Elements Input line and fuses Equipotential ground connector and symbol Shaver Detect power socket Shaver or Output Fuse Access panel (For Arthrex authorized use only) Date of manufacture and serial number label LM1-0630-EN_E Page 7 of 43...

  • Page 14: Ar-6480 Display Messages

    AR-6480 Display Messages The console’s Touch Panel Visual Display (TPVD) [5] provides information about the status of the AR-6480 and the pressure and flow settings in real time. Table 3 describes each message and button when pump is in ready state.
  • Page 15 Product Description DualWave Arthroscopy Pump User’s Guide Message Cause Explanation - Button Pressure set decrease. The TPVD displays the pressure reading until PRESSURE (-) button is pressed. Once pressed, the displayed pressure reading will change to the pressure setting. Each subsequent press of the pressure buttons will decrease the pressure setting in increments of 5.

  • Page 16: 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 Foot Pedal Elements (AR-6483).

  • Page 17: 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 18: Tubing

    2.5.1 Tubing Configurations Figure 5, Figure 6 ReDeuce Tubing Configuration, and Figure 7 Outflow Tubing Configuration show the tubing combinations supported by the AR-6480. Figure 5 Main Pump Tubing Configuration Table 6 Elements of the Main Pump Tubing Configuration Element...

  • Page 19: Figure 6 Redeuce Tubing Configuration

    Product Description DualWave Arthroscopy Pump User’s Guide Element Description Tubing Set Backflow check valve Extension Tubing Figure 6 ReDeuce Tubing Configuration Table 7 Elements of the ReDeuce Tubing Configuration Element Description Tubing Set Bag spikes Y-Adapter Tubing Tubing clamps Y-Adapter Tubing ReDeuce Pump Tubing ReDeuce Patient Tubing Green connector...

  • Page 20: Tubing: Main Pump Tubing Set (Ar-6410)

    Product Description DualWave Arthroscopy Pump User’s Guide Figure 7 Outflow Tubing Configuration (AR-6430) Table 8 Elements of the Outflow Tubing Configuration Element Description Tubing Set Tubing clamp Outflow Shaver attachment Outflow Cannula attachment Outflow Waste egress Outflow Outflow Fixture Outflow Tubing loop for Outflow roller Outflow Paper retaining strap...

  • Page 21: Tubing: Extension Tubing System (Ar-6220)

    Product Description DualWave Arthroscopy Pump User’s Guide For specific information about each tubing set, refer to the Directions for Use that are included with each set or contact your Arthrex representative. 2.5.3 Tubing: Extension Tubing System (AR-6220) The unique Extension Tubing System allows use of the Main Pump Tubing Set for an entire surgical day.

  • Page 22: Technical Specifications

    Technical Specifications DualWave Arthroscopy Pump User’s Guide Technical Specifications 3.1.1 Console Table 9 Control Unit (AR-6480) Specifications Width 16.5 inches (42 cm) Height 7.5 inches (19 cm) Depth 14 inches (35.5 cm) Weight 27 pounds (12.25 kg) Maximum Flow rate...

  • Page 23: Remote Control

    Technical Specifications DualWave Arthroscopy Pump User’s Guide 3.1.3 Remote Control Table 13 Remote Control Unit (AR-6482) Specifications Width 2.5 inches (63.5 mm) Height 3.8 inches (95.3 mm) Depth 0.9 inches (22.2 mm ) Weight 0.5 lbs. (0.23 kg) Cable length 9.8 feet (3 m ) Cleaning Surface cleaning with mild detergent...

  • Page 24: Setup

    AC mains outlet. Please use the appropriate plug and a reliable ground conductor. Arthrex supplies separate power cords for the U.S. and Germany (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. NOTE: Extension cords must meet local electrical standards.

  • Page 25: Replacing The Fuses

    Arthrex instructs. To determine if the AR-6480 is causing interference to other devices, power OFF the AC mains power switch [3] and then ON again.

  • Page 26: Shaver Detection

    Setup DualWave Arthroscopy Pump User’s Guide Connect the receiver end of the power cord for the AR-6480 into the AC socket [14] and the plug end to the facility AC mains supply. Connect the shaver power cord (If shaver detection is desired, otherwise skip to step 5).

  • Page 27: Shaver Detect, Inflow/Outflow

    Setup DualWave Arthroscopy Pump User’s Guide 4.6.2 Shaver Detect, Inflow/Outflow During Inflow/ Outflow operation (Outflow tube set present), the DualWave responds to shaver activation by closing the cannula suction tube and opening the shaver suction tube for fluid egress. The level of suction will automatically change to either the preset shaver suction value, or to the user defined level.

  • Page 28: How To Set Up The Pump Tubing

    • The shaver detect function of the DualWave has been verified to function properly with the Arthrex Adapteur II shaver console. It is the responsibility of the user facility to evaluate 3rd party shaver consoles to determine the correct operating parameters and any potential hazards of utilizing the DualWave with an alternate shaver console.

  • Page 29: How To Set Up The Two-Piece Tubing System

    Close the inflow door. 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 the unused spike.

  • Page 30: 4.10 How To Change The Language Setting

    4.12.2 Overpressure Sensing The sensing circuitry in the AR-6480 measures the pressure of the fluid in the tubing. The overpressure alarm can be activated when the flow is abruptly interrupted or the joint is suddenly positioned in a way which reduces the joint capsule volume (e.g., bending the knee joint to the “Figure 4”...

  • Page 31: Roller Housing

    Setup DualWave Arthroscopy Pump User’s Guide 4.12.3 Roller Housing The pump motor automatically deactivates when the roller housing door is opened. A locking mechanism prevents access to the rotating parts while the device is operating. 4.12.4 Tubing Sensor Coupler The pump motor automatically deactivates when the tubing is disconnected from the pump.

  • Page 32: Operation

    W A R N I N G ! The safety and effectiveness of the AR-6480 is verified and documented; however, the AR-6480 must be used with an awareness of the risk of extra- articular edemas for patients with pathologically changed articular capsules and for procedures involving an opening of the capsule (e.g.

  • Page 33: How To Operate The Ar-6480 In Inflow Only Mode

    How to Operate the AR-6480 in INFLOW ONLY Mode W A R N I N G ! The Extension or Patient Tubing must be replaced before each new surgical procedure.

  • Page 34: How To Operate The Ar-6480 In Inflow/Outflow Mode

    LAVAGE button a second time. 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 or IV] to enable this function. The RINSE button should turn color and begin a countdown.

  • Page 35: Alternative Suction Pathway (Asp) Mode

    RINSE button a second time. Alternative Suction Pathway (ASP) Mode The AR-6480 pump has an ASP function for minimizing clogging issues. The ASP MODE is only accessible in INFLOW/OUTFLOW MODE. In ASP Mode changes the suction pathway from the shaver suction pathway to the cannula suction pathway at the shaver suction level.

  • Page 36: Cleaning And Disinfecting

    DualWave Arthroscopy Pump User’s Guide Cleaning and Disinfecting Console (AR-6480) The AR-6480 console is provided non-sterile and should not be sterilized. The AR-6480 console can be cleaned/disinfected using a cloth and commercially available surfactants or surface disinfectants only. The AR-6480 must not be submersed in any liquid.

  • Page 37: Tubing

    Cleaning and Disinfecting DualWave Arthroscopy Pump User’s Guide Tubing W A R N I N G ! The Extension, Patient, and/or Outflow tubing must be replaced before each new surgical procedure. The tubing is supplied pre-packaged sterile by EO sterilization. Do not re- sterilize.

  • Page 38: Sterilization

    Sterilization DualWave Arthroscopy Pump User’s Guide Sterilization Sterilization capabilities, cleaning, disinfecting, handling, and storage of instrumentation are the responsibility of qualified facility and/or user personnel. Qualified personnel must still properly clean and disinfect the instruments prior to sterilization. Reusable accessories that are provided non-sterile may be sterilized by one of the following methods: Gravity displacement cycles: •...

  • Page 39: Transmissible Spongiform Encephalopathy (Tse)

    Transmissible Spongiform Encephalopathy (TSE) DualWave Arthroscopy Pump User’s Guide Transmissible Spongiform Encephalopathy (TSE) It is outside the scope of this document to describe in detail the precautions that should be taken for Transmissible Spongiform Encephalopathy (TSE) Agents. The agents for transmission of Creutzfeldt-Jakob disease are believed to be resistant to normal processes of disinfection and sterilization.

  • Page 40: Maintenance

    DualWave Arthroscopy Pump User’s Guide Maintenance There is no recommended maintenance schedule. Follow instructions listed in Section 6.0 for cleaning the console and remote control units. If the AR-6480 should malfunction, contact an Arthrex representative or Arthrex Technical Support. LM1-0630-EN_E...

  • Page 41: Technical Support

    DualWave Arthroscopy Pump User’s Guide 10.0 Technical Support For assistance in using the products identified in this User’s Guide, contact an Arthrex representative or call the Arthrex Technical Support Hotline at 1-888-420-9393, Monday through Friday from 9:00 AM to 5:00 PM EST 10.1 How to Display the Software Version...

  • Page 42: Troubleshooting

    DualWave Arthroscopy Pump User’s Guide 11.0 Troubleshooting Contact Arthrex Technical Support immediately in the event of any damage or malfunction of the equipment. Attempt the remedies listed in Table 15, in the order in which they are presented. Table 15...

  • Page 43: Troubleshooting Interference With Other Devices

    Check tubing for damaged and if it is pinched, kinked or blocked. Check tubing for proper connections. Replace tubing. If failure remains, return to Arthrex for repair. No Shaver Detect Ensure Universal shaver cable is connected. Turn On and Off DualWave while the shaver system is powered on.

  • Page 44: Limited Warranty

    Arthrex, F.O.B. Arthrex’s facility. If Arthrex determines that any product or service is not defective or that Arthrex is not liable for the defect, the Customer will be notified; thereafter, Arthrex will repair or replace such product upon the Customer’s written consent and at prevailing prices.

  • Page 45: Repair Policy

    Repair Policy DualWave Arthroscopy Pump User’s Guide 13.0 Repair Policy Contact Arthrex for a Return Authorization Number and instructions prior to returning the device. LM1-0630-EN_E Page 39 of 43...

  • Page 46: Electromagnetic Emissions

    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 assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 47 6480 DualWave Arthroscopy Pump requires on power supply continued operation during power mains input lines 40% UT 60% Reduction interruptions, it is recommended that the AR-6480 (60 % dip in UT) (100ms) DualWave Arthroscopy Pump be powered from IEC 61000-4-11 for 5 cycles an uninterruptible power supply.

  • Page 48: Table 18 Guidance And Manufacturer's Statement - Electromagnetic Immunity

    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. Immunity test...

  • Page 49: Contact Information

    D-85748 Garching/München, Germany Tel: 49 81 31 59 57 0 Fax: 49 81 31 59 57 565 www.arthrex.de 15.1 Compliance Information 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.

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