Arthrex AR-8305 User Manual
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Arthrex AR-8305 User Manual

Synergy resection
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Synergy Resection
User's Guide
The Arthrex Synergy Resection User's Guide provides safety
operation information for all components of the Arthrex Synergy
Resection console (Model AR-8305), including the accessories. All
operating personnel must read this User's Guide thoroughly prior
to using this system and follow all safety warnings, cautions, and
notes.
0086
Arthrex, Inc.
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-0213-7 Revision 0 08/2019
© 2019 Arthrex, Inc. All rights reserved.

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  • Page 1 Synergy Resection User’s Guide The Arthrex Synergy Resection User’s Guide provides safety operation information for all components of the Arthrex Synergy Resection console (Model AR-8305), including the accessories. All operating personnel must read this User’s Guide thoroughly prior to using this system and follow all safety warnings, cautions, and notes.
  • Page 2 This page intentionally left blank...

  • Page 3: Table Of Contents

    AC Power Safety Considerations ..................16 Replacing the Fuses ......................17 Electromagnetic Compatibility ..................17 Basic Setup Procedure for the AR-8305 Console ............18 Setting up a Footswitch ....................19 Setting up the Shaver Handpieces ................... 19 Setting up Other Accessory Handpieces................19 Shutdown Procedure .......................
  • Page 4 Gas Pedal Footswitch ......................35 5.14.3 Multi-Function Footswitches ....................35 5.15 Accessory Handpieces ..................... 35 6.0 CLEANING AND DISINFECTING ..............36 Console AR-8305 ......................36 Footswitches ........................36 Accessory Cable ....................... 37 Accessory Handpieces ..................... 37 7.0 STERILIZATION ....................39 8.0 TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS 40...
  • Page 5 12.0 REPAIR POLICY ....................45 13.0 END OF LIFE, ENVIRONMENTAL DIRECTIVES ......... 45 14.0 ELECTROMAGNETIC EMISSIONS ..............46 List of Figures Figure 1 Front Panel of Console ......................8 Figure 2 Rear Panel of Console ......................9 Figure 3 Standard Footswitch - Description .................. 13 Figure 4 Main Screen Display - One Tool Attached ..............
  • Page 6 Table 6 AR-8305 Console Specifications ..................14 Table 7 Standard Footswitch Specifications ................14 Table 8 AR-8305 Ambient Conditions for Operation ..............14 Table 9 AR-8305 Ambient Conditions for Storage ..............14 Table 10 Safety, EMC, and Regulatory Requirements ..............15 Table 11 Main Screen Display Elements ..................

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

    6. Do not have device in direct contact with patient if high-frequency devices are in use, or if the patient requires defibrillation. 7. DO NOT stack or place equipment adjacent to the AR-8305 console, if possible. If such a configuration is necessary, carefully observe the configuration in question to ensure that electromagnetic interference does not degrade performance.
  • Page 8 3. Avoid position console so that it is difficult to disconnect coupler or plug from supply main. 4. Connecting an extension cord to the AR-8305 may result in a reduced level of safety. 5. Always use fuses with the correct values to avoid allowing overcurrent to enter the system.
  • Page 9 3. The AR-8305 console incorporates a universal AC input power supply. A voltage selection switch is not required. 4. AR-8305 has been designed to accept EMC from other devices within the limitations as described in section 14.0. 5. The setup for a footswitch is the same for all models. The console detects which version is attached and allows the appropriate functions.

  • Page 10: Symbol Definitions

    General Warnings and Safety Notices - Read This First Synergy Resection User’s Guide Symbol Definitions Caution: Federal Law Safety Sign Restricts this device to Follow Operating sale by or on the order Instructions of a Physician. On / Off (push-push) Type BF Equipment Precaution of Warning Fragile...
  • Page 11 General Warnings and Safety Notices - Read This First Synergy Resection User’s Guide Date of Manufacture; Manufacturer year and month. Handpiece connection Foot Pedal connection Universal Serial Bus Serial Port [Arthrex [For use ONLY with RS-232 Integration] thumb drive] The product meets the essential requirements Catalog number...

  • Page 12: Shipping, Unpacking, And Warranty Information

    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 13: Product Description

    Synergy Resection User’s Guide 2.0 Product Description Product Description and Intended Use The Arthrex AR-8305 Synergy Resection Shaver System is a motorized, suction/cutting device used for the resection and aspiration of soft tissue, cartilage and bone during arthroscopic surgical procedures.

  • Page 14: Product Features

    This device should not be used by untrained personnel or used for indications other than those described in this User’s Guide. Product Features AR-8305Console - Front View Figure 1 shows the front panel of the AR-8305 console. Features and symbols are identified in Table 1 below. Figure 1 Front Panel of Console...

  • Page 15: Ar-8305 Console - Rear View

    The console's Touch Panel Visual Display (TPVD) [5] provides information about the status of the AR-8305 settings in real time. A list of informational and error messages is shown in Table 3 and 4 below. Messages that represent the active motor states are displayed in green on the TPVD.

  • Page 16: Table 3 Ar-8305 Display Messages

    Product Description Synergy Resection User’s Guide Table 3 AR-8305 Display Messages Message Explanation **EEPROM Reset** Temporarily displayed first time micro- controller is programmed, or if internal memory has faulted and is reset. **Motor Fault** Temporarily displayed when motor fault condition occurs.
  • Page 17 Product Description Synergy Resection User’s Guide Current mode: Efficient oscillation mode (stopped). FC Shaver Footswitch Controlling Shaver connected. Current mode: Forward (stopped). Current status: Motor is moving forward. Gas Pedal Footswitch Temporarily displayed when gas pedal footswitch connected. Gas Pedal Footswitch Connected. HC Shaver Handpiece Controlling Shaver connected.

  • Page 18: Table 4 *Tool Failure* Error Code Definitions

    Product Description Synergy Resection User’s Guide Table 4 *TOOL FAILURE* Error Code Definitions Message Explanation # $ @ Represents Handpiece Sensor Failures # = Sensor 3, $ = Sensor 2, @ = Sensor 1 Example: 022 0 = Stuck Low, Sensor 3 = Stuck Low 1 = Stuck High, Sensor 2 = No Errors Found...

  • Page 19: Applied Parts And Accessory Features

    Product Description Synergy Resection User’s Guide Applied Parts and Accessory Features Standard Footswitch (AR-8310) Figure 3 shows the Standard Footswitch. Features and symbols are identified in Table 5 below. Figure 3 Standard Footswitch - Description Table 5 Elements of the Standard Footswitch 1.

  • Page 20: Technical Specifications

    Cleaning, disinfecting, and Refer to Sections 6.0 Cleaning and Disinfecting sterilization and Section 7.0 Sterilization Ambient Conditions for Operation Table 8 AR-8305 Ambient Conditions for Operation Temperature 10° to 40°C (50° to 104°F) Relative humidity 30 % to 75 % Air Pressure 700 hPa to 1060 hPa (21 in.

  • Page 21: Safety, Emc, And Regulatory Requirements

    Technical Specifications Synergy Resection User’s Guide Safety, EMC, and Regulatory Requirements Table 10 Safety, EMC, and Regulatory Requirements Parameter Parameter Value FDA Class Class 1 System EU Class Class IIA Classification Health Canada Class Class 2 Domestic Certification UL 60601-1:2003 Safety Canadian Certification CAN/CSA C22.2 No.

  • Page 22: Setup

    AC Power Safety Considerations The AR-8305 is powered by a medically rated universal AC input switching power supply. 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.

  • Page 23: Replacing The Fuses

    Arthrex instructs. AR-8305 has been designed to accept EMC from other devices within the limitations as described in section 14.0. To determine if the AR-8305 is causing interference to other devices, power OFF the AC main power switch and then ON again.

  • Page 24: Basic Setup Procedure For The Ar-8305 Console

    Place the AR-8305 on a flat, dry surface, such as the AR-6481 Arthrex Arthroscopy pump cart. Connect the receiver end of the power cord for the AR-8305 into the AC socket and the plug end to the facility AC mains supply.

  • Page 25: Setting Up A Footswitch

    Connect the other end of the accessory cable to the handpiece receptacle of the console. Align the red dots on the connector and receptacle so they engage easily. Shutdown Procedure The AR-8305 can be safely shut down at any time by powering down the console. DFU-0213-7 Rev. 0 Page 19 of 50...

  • Page 26: Operation And Frequently Used Functions

    Operation and Frequently Used Functions Synergy Resection User’s Guide 5.0 Operation and Frequently Used Functions Main Screen Figure 4 Main Screen Display - One Tool Attached Figure 5 Main Screen Display - Two Tools Attached Table 11 Main Screen Display Elements The main screen, divided into two sections when two tools are attached Settings button (on the lower right corner in the single screen mode) Up button...

  • Page 27: Settings Menu Main Screen

    Operation and Frequently Used Functions Synergy Resection User’s Guide Direction and Oscillation buttons • The main screen is divided horizontally into two sections, one for each channel, when tools are connected to both channels. • Each section contains a display area for messages and five buttons. •...

  • Page 28: Table 12 Settings Menu Display - Operation

    Operation and Frequently Used Functions Synergy Resection User’s Guide Table 12 Settings Menu Display - Operation Select Language When the Select Language button is pressed, the button software displays the Language Selection screen, section 5.3 below. Select Oscillation When the Select Oscillation Mode button is Mode button pressed, the software displays the Oscillation Mode screen, section 5.4 below.

  • Page 29: Language Selection Screen

    Operation and Frequently Used Functions Synergy Resection User’s Guide Language Selection Screen The Language Selection screen displays a list of available languages with radio buttons. The software supports the following languages: English, German, French, Italian and Spanish. It also includes three navigation buttons: Menu, Home and Cancel as described in Table 13 below.

  • Page 30: Oscillation Mode Selection Screen

    Operation and Frequently Used Functions Synergy Resection User’s Guide Oscillation Mode Selection Screen The Oscillation Mode selection screen has radio buttons for available oscillation modes for each channel. This screen also includes Menu, Home and Cancel buttons as described in Table 14 below: Figure 8 Oscillation Mode Selection Screen - Operation Table 14...

  • Page 31: Footswitch Override Screen

    Operation and Frequently Used Functions Synergy Resection User’s Guide Footswitch Override Screen The Footswitch Override screen has radio buttons to select the footswitch override mode for each channel. At the End User’s discretion, the default setting can be changed so that the Shaver Handpiece can be controlled by both the Footswitch and/or the Hand Controls as described below.

  • Page 32: Reset Defaults Screen

    Operation and Frequently Used Functions Synergy Resection User’s Guide Reset Defaults Screen The Reset Defaults screen prompts the user to confirm resetting to factory defaults. This screen is displayed when the Reset Defaults button is pressed on the Settings screen. Figure 10 Reset Defaults Screen - Operation The software displays two buttons that allows the user to confirm resetting of...

  • Page 33: Information Screen

    Operation and Frequently Used Functions Synergy Resection User’s Guide Information Screen The Information screen displays the Model, Software Versions and Builds for each controller, along with Menu and Home buttons as described in Table 17 below: Figure 11 Information Screen - Operation Table 17 Information Screen Display - Operation Model, Software Versions &...

  • Page 34: Buttons

    Operation and Frequently Used Functions Synergy Resection User’s Guide Buttons Most buttons send a message to the controller when activated and/or released. The Up and Down speed buttons auto repeat when pressure is maintained. The selected speed is not sent to the controller until the button is released. Buttons - Main Screen The Main Screen is displayed in one of two configurations depending on how many handpieces are connected to the system.

  • Page 35: Figure 13 Two Handpiece Buttons - Operation

    Operation and Frequently Used Functions Synergy Resection User’s Guide Figure 13 Two Handpiece Buttons - Operation Table 19 Two Handpiece Buttons - Operation Channel 1 Reverse When the Reverse button is pressed, the button handpiece motor moves in a counterclockwise Channel 2 Reverse direction when observed from the tip of the button...

  • Page 36: Speed Test Mode

    Operation and Frequently Used Functions Synergy Resection User’s Guide Channel 1 Down button When the Down button is pressed, the speed of 10. Channel 2 Down button the motor decreases. The decrease of the motor speed depends on the type of the handpiece. When the Down button is initially pressed, during the first second, the speed changes by one increment.

  • Page 37: Accessory Handpiece Speed Limits And Deltas

    Operation and Frequently Used Functions Synergy Resection User’s Guide Accessory Handpiece Speed Limits and Deltas The console supports individual handpiece motor-speed limits, defaults, and speed increment and decrement “deltas”. These are defined below for the supported handpieces. Table 20 Accessory Handpiece Speed Limits and Delta Forward / Reverse Speeds Oscillation Speeds (RPM)

  • Page 38: Attachment Motor Control

    Operation and Frequently Used Functions Synergy Resection User’s Guide Attachment Motor Control Definition of Direction The definition of direction as viewed looking from the proximal to the distal (top of the tip) of the shaver handpiece. Reverse Counterclockwise (CCW) Forward Clockwise (CW) Oscillation CW then CCW...

  • Page 39: Toggle Function

    Operation and Frequently Used Functions Synergy Resection User’s Guide 5.13.3.2 Cruise Lock The LOCK IN period lasts for up to 15 seconds. During the LOCK IN period the operator adjusts the speed and must hold the pedal steady for 3 seconds in order for the LOCKED state to occur. Steady is defined as ±500 RPM for forward or reverse, and ±400 RPM for oscillation.

  • Page 40: Table 22 Toggle Function

    Operation and Frequently Used Functions Synergy Resection User’s Guide When the user presses Toggle again, the footswitch returns control to the handpiece on the same channel as the footswitch. The channel on the opposite side as the footswitch is controlled by front panel buttons only. When controlled by the footswitch, the HC shaver is controlled by the Footswitch Override setting.

  • Page 41: Footswitches

    Operation and Frequently Used Functions Synergy Resection User’s Guide Footswitches The footswitch cable connects and locks to the console to prevent accidental separation during use. To avoid damage, disconnect the footswitch by pulling on the cable connector shell (plug) only. Standard Footswitch The Speed Increase button adjusts the speed in the positive direction only.

  • Page 42: Cleaning And Disinfecting

    The AR-8305 console is provided non-sterile and must not be sterilized. The AR-8305 console can be cleaned/disinfected using a cloth and commercially available surfactants or surface disinfectants only. Use a commercially available cleaning disinfectant for surfaces. Alkaline agents with a pH value > 8 are to be avoided Do NOT clean the device with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch or damage the device.

  • Page 43: Accessory Cable

    (DFU-0154-XX, or DFU-0240-XX) and Adapteur Power System II Accessory Attachments (DFU-0149-XX) cleaning and sterilization instructions included with each handpiece. Additional copies of this insert can be obtained from the Arthrex website at www.Arthrex.com, or by contacting your local Arthrex Representative.
  • Page 44 Cleaning and Disinfecting Synergy Resection User’s Guide Remove any accessories in the device. This includes shaver blades, saw blades or drill bits. If the handpiece has suction control, make sure it is fully open. Clean the handpiece with an enzymatic cleaner without subsequent acid neutralization.

  • Page 45: Sterilization

    Handpiece (DFU-0154-XX or DFU-0240-XX) and Adapteur Power System II Accessory Attachments (DFU-0149-XX) cleaning and sterilization instructions included with each handpiece. Additional copies of this insert can be obtained from the Arthrex website at www.Arthrex.com, or by contacting your local Arthrex Representative.

  • Page 46: Transmissible Spongiform Encephalopathy (Tse) Agents

    Transmissible Spongiform Encephalopathy (TSE) Agents Synergy Resection User’s Guide 8.0 Transmissible Spongiform Encephalopathy (TSE) Agents 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 47: Maintenance

    Your authorized Arthrex service department is the most knowledgeable about the Arthrex Medical Resection Systems and/ foot pedal and handpiece, and will provide competent and efficient service. Any services and/or repairs done by any unauthorized repair facility may result in reduced performance of the instruments or instrument failure.

  • Page 48: Technical Support

    Synergy Resection User’s Guide 10.0 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 (800) 391-8599, Monday through Friday from 8:00 AM to 8:00 PM EST; at +49 89 909005-0 or techsupport@arthrex.de...

  • Page 49: Troubleshooting

    Troubleshooting Synergy Resection User’s Guide 11.0 Troubleshooting Refer to Table 23 for device troubleshooting if problems occur after cleaning, transporting or changing operating staff. Table 23 Troubleshooting: Faults, their Causes and Solutions Fault Cause Solution Unit does not power on. 1.

  • Page 50: Troubleshooting Interference With Other Devices

    4. Send in for repairs. If the problems persist, disinfect the Synergy Resection System and send in to Arthrex using the original packaging. Always send the corresponding handpiece together with the console, footswitch and cable. Please enclose a brief explanation of the detected malfunction.

  • Page 51: Repair Policy

    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 52: Electromagnetic Emissions

    Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The AR-8305 Shaver System is intended for use in the electromagnetic environment specified below. The customer or the user of the AR-8305 Shaver System should assure that it is used in such an environment.

  • Page 53: Table 26 Guidance And Manufacturer's Statement - Electromagnetic Immunity

    Guidance and Manufacturer's Statement - Electromagnetic Immunity The AR-8305 Synergy Resection System is intended for use in the electromagnetic environment specified below. The customer or the user of the AR-8305 Synergy Resection System should ensure that it is used in such an environment.
  • Page 54 If the measured field strength in the location in which the Model AR 8305is used exceeds the applicable RF compliance level above, the Model AR-8305 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Model AR-8305 b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

  • Page 55: Table 27 Guidance And Manufacturer's Statement - Recommend Separation Distance

    Model AR-8305 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Model AR-8305 as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter [m]...
  • Page 56 Synergy Resection User’s Guide 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...

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