Arthrex DrillSaw Sports 400 User Manual
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Arthrex DrillSaw Sports 400 User Manual

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DFU-0256-1, Rev. 0
English
Universal DrillSaw™ Battery
Charger
User's Guide
The Arthrex Universal DrillSaw Battery Charger User's Guide
provides safety operation information for all components of
the Arthrex Universal DrillSaw Battery Charger, 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.
0086
Arthrex, Inc.
1370 Creekside Blvd.
Naples, FL 34108-1945 USA
Toll Free: 1-(800) 934-4404
www.arthrex.com
Erwin-Hielscher-Strasse 9
81249 München, Germany
Tel: +49 89 909005-0
Fax: +49 89 909005-280
www.arthrex.de
DFU-0256-1
Revision 0
© 2016 Arthrex, Inc. All rights reserved
Arthrex GmbH

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  • Page 1 English Universal DrillSaw™ Battery Charger User’s Guide The Arthrex Universal DrillSaw Battery Charger User’s Guide provides safety operation information for all components of the Arthrex Universal DrillSaw Battery Charger, 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 2 This page intentionally left blank...

  • 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 ..........5 0 Product Description and Intended Use ..........6 Product Description .................... 6 Intended Use ......................
  • Page 4 Table of contents 0 Maintenance ..................26 Periodic Maintenance ..................26 0 Technical Support................27 Additional Technical Information ..............27 0 Troubleshooting ................28 0 Repair Policy ..................30 0 End of Life, Environmental Directives ..........31 0 Electromagnetic Emissions ............... 32 List of Figures Figure 1 Front Panel of the Charger ....................
  • Page 5 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 6: General Warnings And Safety Notices - Read This First

    Universal DrillSaw Battery Charger User’s Guide identifies critical, important, and useful information using these symbols and conventions. 1.1 Important Safety Conventions Users of this device are encouraged to contact their Arthrex representative if they require a more comprehensive surgical technique. W A R N I N G ! The WARNING! label is the most important safety symbol.
  • Page 7 3. This device has passed testing for EMI / RFI radiation and susceptibility, and EMC compatibility. This device may cause interference with other devices in the near vicinity if not set up, and used as instructed by Arthrex. 4. DO NOT clean the device with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch or damage the device.
  • Page 8 1. Read this User’s Guide thoroughly before operating the device and save it for future reference. For additional information and training, contact your local Arthrex representative. 2. The AR-400UBC charger incorporates a universal AC input power supply. A voltage selection switch is not required.

  • Page 9: Symbols Definition

    Universal DrillSaw Battery Charger User’s Guide 1.2 Symbols Definition Caution: Federal law Safety Sign restricts this device to Follow operating sale by or on the instructions order of a physician. Fragile, handle with Non sterile care Caution This side up Temperature limits for Keep dry storage and transport...

  • Page 10: Shipping, Unpacking, And Warranty Information

    Carefully unpack and inspect all components for shipping damage. Any damage could compromise patient safety and should be reported immediately to Arthrex or any authorized Arthrex distributor. The warranty could be voided if shipping or first-installation damage is not reported within seven business days of receiving the device.

  • Page 11: Product Description And Intended Use

    Universal DrillSaw Battery Charger User’s Guide 0 Product Description and Intended Use 2.1 Product Description The Arthrex Universal DrillSaw Battery Charger is classified as a FDA Class I medical device. The Arthrex Universal DrillSaw Battery Charger is designed to charge the following...
  • Page 12 Universal DrillSaw Battery Charger User’s Guide Only use Arthrex accessories described in this User’s Guide. W A R N I N G ! Misuse may damage the AR-400UBC and cause risks and hazards for patients, users and third parties. W A R N I N G ! This device is only for use under the supervision of a trained and licensed physician.

  • Page 13: Product Features

    Universal DrillSaw Battery Charger User’s Guide 2.4 Product Features AR-400UBC Universal DrillSaw Battery Charger – Front View Figure 1 shows the front panel of the AR-400UBC. The features are identified in Table 1 below. Figure 1 Front Panel of the Charger Table 1 Front Panel of the Charger Charging Bay No.1...

  • Page 14: Ar-400Ubc Universal Drillsaw Battery Charger - Rear View

    Universal DrillSaw Battery Charger User’s Guide 2 AR-400UBC Universal DrillSaw Battery Charger – Rear View Figure 2 shows the rear panel of the AR-400UBC. The features are identified in Table 2 below. Figure 2 Rear Panel of the Charger Table 2 Rear Panel of the Charger ON/ OFF Power Switch Supply main input Plug...

  • Page 15: Ar-400Ubc Display Messages

    The Touch Screen Display [Figure 1] provides information about the status of the AR-400UBC charging status in real time. A list of informational and error messages is shown in Table 3 below. Messages shaded in gray denote that Arthrex technical support should be contacted for further instructions.

  • Page 16: Ar-400Ubc-4 Charging Bay For Ar-400Ub Batteries

    Universal DrillSaw Battery Charger User’s Guide 4 AR-400UBC-4 Charging bay for AR-400UB Batteries Figure 3. shows the Charging bay for the AR-400UB Battery Pack. The features are identified in Table 4 below. Figure 3 Charging bay for AR-400UB Batteries Table 4 Elements of the Charging bay for AR-400UB Batteries Battery contact Alignment tabs for connecting to the charger...

  • Page 17: Ar-400Ubc-3 Charging Bay For Ar-300 And Ar-600 Batteries

    Universal DrillSaw Battery Charger User’s Guide 5 AR-400UBC-3 Charging bay for AR-300 and AR-600 Batteries Figure 4. shows the Charging bay for AR-300L and AR-600L Battery Packs. The features and symbols are identified in Table 5 below. Figure 4 Charging bay for AR-300 and AR-600 Batteries Table 5 Elements of the Charging bay for AR-300L &...

  • Page 18: Technical Specifications

    Universal DrillSaw Battery Charger User’s Guide 0 Technical Specifications 3.1 Charger Table 6 AR-400UBC Charger Width 330 mm (13 in.) Height 100 mm (4 in.) Depth 280 mm (11 in.) Weight 2.65 kg (5.9 lbs.) Water protection IP30 AC Input 100-240V~, 50/60Hz, 3 A, Class I Mains Fuse 5A (Non-Replaceable)

  • Page 19: Safety, Emc, And Regulatory Requirements

    Universal DrillSaw Battery Charger User’s Guide 3.2 Safety, EMC, and Regulatory Requirements Table 9 Safety, EMC, and Regulatory Requirements Parameter Parameter Value System Classification IEC 60601-1 Class I (protection against electric shock) FDA class Class I medical device (non- sterile) EU class Class IIa Health Canada Class...

  • Page 20: Electromagnetic Compatibility (Emc)

    EMC compatibility. This device may cause interference with other devices in the near vicinity if not set up and used as instructed by Arthrex. The AR-400UBC has been designed to accept EMC from other devices within the limitations as described in section 13.0.

  • Page 21: Setup

    AC mains outlet. Arthrex supplies separate region specific power cords (Hospital grade and EU) with the AR-400UBC. Contact your Arthrex representative if you need a power cord that must meet the electrical standards of another country. Only use replacement power cords that comply with medical grade standards, IEC 60320-1 Subclause 3.21, Detachable Power Supply...

  • Page 22: Basic Setup Procedure For The Ar-400Ubc Charger

    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. Failure to comply may result in patient and/or operating room staff injury.

  • Page 23: Setup - Installing A Charging Bay

    Universal DrillSaw Battery Charger User’s Guide 4.3 Setup - Installing a charging bay These instructions describe how to install charging bay(s) Figure 5 Install a charging bay Table 10 Install a charging bay With the power off, using the hex-wrench provided on the bottom of the charger, remove the securement screw and the protective bay cap used during shipping.

  • Page 24: Setup - Battery Installation And Removal

    Universal DrillSaw Battery Charger User’s Guide 4.4 Setup – Battery Installation and Removal These instructions describe how to install/remove batteries to the charger: Figure 6 Battery Attachment and Removal: DFU-0256-1 Rev. 0 Page 19 of 35...

  • Page 25: Table 11 Battery Attachment And Removal

    Universal DrillSaw Battery Charger User’s Guide Table 11 Battery Attachment and Removal These pictures represent how to insert a battery onto a charging bay. The black arrows indicate the direction of insertion. Note: AR-300L batteries are placed on the charger in the same manner as the AR-600L batteries.

  • Page 26: Operation And Frequently Used Functions

    Universal DrillSaw Battery Charger User’s Guide 0 Operation and frequently used functions Users of this device should contact their Arthrex representative if they require more comprehensive assistance. 5.1 Main Screen NOTE: If the light doesn’t appear within 5 seconds, the charger did not identify the battery.

  • Page 27: Options Screen Display

    Universal DrillSaw Battery Charger User’s Guide 5.2 Options Screen Display The Options Sreen provides access to settings and information screens. Figure 8 Options Screen Display Table 13 Options Screen Display Brightness adjustment. Model, Serial Number, Manufacture Date, and Firmware Version for each charger.

  • Page 28: Cycle Screen Display (Only Available For Ar-400 Batteries)

    Universal DrillSaw Battery Charger User’s Guide 5.3 Cycle Screen Display (Only available for AR-400 Batteries) The Cycle Screen provides information about the numbers of charging cycles . Figure 9 Cycle Screen Display Table 144 Options Screen Display Number of charging cycles for the battery being charged (only available for AR-400 Batteries) Exit Button - returns the user to the charging screen.

  • Page 29: Cleaning And Disinfecting

    Universal DrillSaw Battery Charger User’s Guide 0 Cleaning and Disinfecting 6.1 Charger AR-400UBC The AR-400UBC charger is provided non-sterile and should not be sterilized. The AR-400UBC charger can be cleaned/disinfected using a cloth and commercially available surfactants or surface disinfectants only. The AR-400UBC must not be submersed in any liquid.

  • Page 30: Sterilization

    Universal DrillSaw Battery Charger User’s Guide 0 Sterilization The charger and charging cups may not be sterilized, they can only be dissinfected. Follow the cleaning and disinfrecting guidelines in Section 6.0. 7.1 Transmissible Spongiform Encephalopathy 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.

  • Page 31: Maintenance

    The product should be inspected prior to and after each use to ensure that the charger and accessories are not damaged or worn. If it becomes necessary to return the charger to Arthrex for service, please disinfect the unit before shipping. DFU-0256-1 Rev. 0...

  • Page 32: Technical Support

    Universal DrillSaw Battery Charger 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 or techsupport@arthrex.de from 8:00 AM to 5:00 PM CET.

  • Page 33: Troubleshooting

    2. Not receiving power Check the main power plug and wall from the wall receptacle receptacle. or the power strip. Return to Arthrex for repairs. 3. Charger has an internal power failure. Charging cups Bent connector, or Detach the charger cup from the charger and:...
  • Page 34 If the problems persist, clean and disinfect the Universal DrillSaw Battery Charger and send it to Arthrex using the original packaging when possible. Please enclose a brief explanation of the malfunction detected, along with any charging bay cups that were used when the problem occurred.

  • Page 35: 1 . 0 Repair Policy

    Universal DrillSaw Battery Charger User’s Guide 0 Repair Policy Contact Arthrex for a return authorization number and instructions prior to returning the device. DFU-0256-1 Rev. 0 Page 30 of 35...

  • Page 36: 2 . 0 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 37: 3 . 0 Electromagnetic Emissions

    0 Electromagnetic Emissions Table 177 Guidance and Manufacturer's Declaration - Electromagnetic Emissions The Universal DrillSaw Battery Charger is intended for use in the electromagnetic environment specified below. The customer or the user of the Universal DrillSaw Battery Charger System should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...

  • Page 38: Table 18 Guidance And Manufacturer's Statement - Electromagnetic Immunity

    Table 188 Guidance and Manufacturer's Statement - Electromagnetic Immunity The Universal DrillSaw Battery Charger is intended for use in the electromagnetic environment specified below. The customer or the user of Universal DrillSaw Battery Charger should ensure that it is used in such an environment. Immunity test IEC 60601 test Compliance level...

  • Page 39: Table 19 Guidance And Manufacturer's Statement - Electromagnetic Immunity (Cont'd)

    Table 199 Guidance and Manufacturer's Statement - Electromagnetic Immunity (cont’d) The Universal DrillSaw Battery Charger is intended for use in the electromagnetic environment specified below. The customer or the user of the Universal DrillSaw Battery Charger should ensure that it is used in such an environment. Immunity IEC 60601 Compliance...
  • Page 40 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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Ar-400ubc

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