Arthrex DrillSaw Mini 300 System User Manual
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Arthrex DrillSaw Mini 300 System User Manual

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DrillSaw Mini 300™ System
User's Guide
The Arthrex DrillSaw Mini 300™ System User's Guide provides
safety operation information for all components of the
Arthrex DrillSaw Mini 300™ System, 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
Arthrex GmbH
Erwin-Hielscher-Strasse 9
81249 München, Germany
Tel: +49 89 909005-0
Fax: +49 89 909005-280
www.arthrex.de
DFU-0223-2
Revision 0
© 1/2019 Arthrex, Inc. All rights reserved

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Summary of Contents for Arthrex DrillSaw Mini 300 System

  • Page 1 DrillSaw Mini 300™ System User’s Guide The Arthrex DrillSaw Mini 300™ System User’s Guide provides safety operation information for all components of the Arthrex DrillSaw Mini 300™ System, 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 General Warnings and Safety Notices - Read This First ....1 Important Safety Conventions ................1 Symbol Definitions ..................... 4 Shipping, Unpacking, and Warranty Information ..........5 Product Description and Intended Use ..........6 Product Description .................... 6 Intended Use ......................
  • Page 4 Table of contents Battery Pack ..................... 25 Preliminary Cleaning ..................26 Handpieces and Battery Housings ...............26 Attachments and Transfer Plates .................26 Automated Cleaning and Thermal Disinfection ..........27 Sterilization ..................28 Approved Sterilization ..................28 Transmissible Spongiform Encephalopathy Agents ......... 29 Maintenance ..................
  • Page 5 Table of contents List of Figures Figure 1 Handpiece ..........................8 Figure 2 AR-300L Battery Pack ......................9 Figure 3 Battery Housing........................10 Figure 4 Connecting and removing an attachment ................ 15 Figure 5 Connecting a battery housing .................... 16 Figure 6 Removing the battery housing ..................

  • Page 6: Electromagnetic Emissions 34

    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

    User’s Guide. Before using the DrillSaw Mini 300 System for the first time, store it at room temperature for 24 hours. Charge batteries before every use. Follow instructions for charging batteries before use.
  • Page 8 21. To avoid potential injury, never allow a rotary or saw attachment to make contact with the surrounding soft tissues and vessels. 22. Never use the Arthrex DrillSaw Mini 300 System in areas near strong magnetic fields. 23. Do not place the handpiece on the patient.
  • Page 9 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. Do not attach accessories to the handpiece unless the handpiece is in the safe mode.

  • Page 10: Symbol Definitions

    DrillSaw Mini 300™ System User’s Guide 1.2 Symbol Definitions Caution: Federal law Safety Sign restricts this device to Follow operating sale by or on the order instructions of a physician. Fragile, handle with Non sterile care Caution This side up Temperature limits for Keep dry storage and transport...

  • Page 11: 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 an 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 12: Product Description And Intended Use

    • Only use Arthrex accessories. W A R N I N G ! Misuse may damage the DrillSaw Mini 300 System 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: Set Composition

    DrillSaw Mini 300™ System User’s Guide 2.4 Set Composition Arthrex DrillSaw Mini 300 System parts and accessories: Handpiece • Attachments (See Table 22) • Battery pack • Battery housing (aseptic battery only) • Battery transfer plate (aseptic battery only) •...

  • Page 14: Product Functions

    DrillSaw Mini 300™ System User’s Guide 2.5 Product Functions AR-300 Handpiece The handpiece functions are identified and defined below. Figure 1 Handpiece Table 1 Handpiece Chuck mechanism Speed regulator Battery housing R/S/F Switch Forward drive (F) Safe position (S) Reverse drive (R) DFU-0223-2 Rev.

  • Page 15: Ar-300L Battery Pack, Li-Ion

    DrillSaw Mini 300™ System User’s Guide AR-300L Battery Pack, Li-Ion The main elements of the AR-300L battery pack are identified and defined below. Figure 2 Battery Pack Table 2 Battery Pack Battery contacts Handle DFU-0223-2 Rev. 0 Page 9...

  • Page 16: Ar-3000Lbh Battery Housing

    DrillSaw Mini 300™ System User’s Guide AR-3000LBH Battery Housing The main elements of the Battery Housing are identified and defined below. Figure 3 Battery Housing Table 3 Battery Housing Battery contacts Battery housing door Release tab to remove battery housing from handpiece DFU-0223-2 Rev.

  • Page 17: Technical Specifications

    30 sec on / 30 sec off for 5 cycles, then wait 48 minutes Following the duty cycle is an important part of maintaining the Arthrex Mini 300 Power System. The duty cycle times have been determined under average load, using the Sagittal Saw attachment and at ambient air temperature of 25°...

  • Page 18: Attachments

    DrillSaw Mini 300™ System User’s Guide 3.2 Attachments Table 7 Attachments Drill Speed 2.750 rpm 1.300 rpm Drill Torque 24 Ncm (2.12 inch pounds) 45 Ncm ( 3.98 inch pounds) Reamer Speed 500 rpm Reamer Torque 1.15 Nm ( 10.17 inch pounds) Cutting 15,000 cpm Sterilization...

  • Page 19: Safety, Emc, And Regulatory Requirements

    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. DFU-0223-2 Rev. 0 Page 13...

  • Page 20: Risks Due To Electromagnetic Fields

    DrillSaw Mini 300™ System User’s Guide The DrillSaw Mini 300 System has been designed to accept EMC from other devices within the limitations as described in section 11.0. Try to correct the interference by following one or more of these measures: Reorient or relocate the receiving device.

  • Page 21: Setup

    DrillSaw Mini 300™ System User’s Guide Setup How to Set Up the Handpiece Users are encouraged to contact their Arthrex representative if they require a more comprehensive surgical technique. Setup - Connecting and removing an attachment to the handpiece These instructions describe the procedure for connecting an attachment to the AR- 300 handpiece.

  • Page 22: Setup - Connecting A Battery Housing To The Handpiece

    DrillSaw Mini 300™ System User’s Guide W A R N I N G ! Always ensure that the handpiece is in safe mode when connecting and disconnecting attachments and accessories. 4.3 Setup - Connecting a battery housing to the handpiece These instructions describe the procedure for connecting a battery to the AR-300 handpiece.

  • Page 23: Setup - Removing The Battery Housing From The Handpiece

    DrillSaw Mini 300™ System User’s Guide 4.4 Setup - Removing the battery housing from the handpiece These instructions describe the procedure for removing the battery housing assembly from the AR-300 handpiece. Figure 6 Removing the battery housing Table 11 Removing the battery housing Pressing the locking device and hold.

  • Page 24: Setup - Quick Connect Of Drilling And Reaming Attachments

    DrillSaw Mini 300™ System User’s Guide 4.5 Setup - Quick Connect of Drilling and Reaming Attachments These instructions describe the procedure to inserting a drill bit into the AR-300 quick connect attachments. Insert a drill bit Figure 7 Insert a drill bit Table 12 Pull back on the quick connect collar and hold it in place.

  • Page 25: Setup - Drilling And Reaming Attachments, Keyed Jacobs Chuck

    DrillSaw Mini 300™ System User’s Guide 4.6 Setup - Drilling and Reaming Attachments, Keyed Jacobs Chuck These instructions describe the procedure for inserting a drill bit to the AR-300 keyed chucks. Insert a drill bit into a Jacobs Chuck Figure 8 Insert a drill bit into a Table 13 Jacobs Chuck...

  • Page 26: Setup - Drilling And Reaming Attachments, Keyless Chuck

    DrillSaw Mini 300™ System User’s Guide 4.7 Setup - Drilling and Reaming Attachments, Keyless Chuck inserting a drill bit These instructions describe the procedure for to the AR-300 keyless attachments. Insert a drill bit into a Keyless Chuck Figure 9 Insert a drill bit into a Keyless Table 14 Chuck...

  • Page 27: Setup - Saw Attachment

    DrillSaw Mini 300™ System User’s Guide 4.8 Setup - Saw Attachment inserting a sawblade These instructions describe the procedure for to the AR-300 sagittal saw attachments and reciprocating saw attachment. Insert a sawblade Figure 10 Insert a sawblade Table 15 Operate the twist chuck or the push-button and push the saw in as far as it will go.

  • Page 28: Setup - Burr / Drill Attachments

    DrillSaw Mini 300™ System User’s Guide 4.9 Setup – Burr / Drill Attachments These instructions describe the procedure for connecting the burr to the burr / drill attachment. Insert a drill / burr bit Figure 11 Insert a burr / drill bit Table 16 Operate the twist chuck Push the rotary instrument in and turn it until you hear it engage.

  • Page 29: Setup - Wire/Pin Driver Attachment

    DrillSaw Mini 300™ System User’s Guide 4.10 Setup - Wire/Pin Driver Attachment inserting a pin These instructions describe the procedure for to the AR-300 pin driver attachment. Insert a pin / wire Figure 12 Insert a pin / wire Table 17 Pull the lever of the pin or wire driver back and insert the pin or wire.

  • Page 30: Battery Housing/Battery Pack/Transfer Plate

    DrillSaw Mini 300™ System User’s Guide 4.11 Battery Housing/Battery Pack/Transfer Plate These instructions describe the procedure for inserting the battery into the battery housing from the AR-300. Insert drop-in battery to the Battery Housing Figure 13 Drop-in battery Table 18 Sterile Technician Non-sterile Circulating Nurse The Sterile Technician holds sterile battery housing upright and...

  • Page 31: Cleaning And Disinfecting

    Always wear proper PPE (Personal Protective Equipment) such as: gloves, eye protection, face shields, gowns, etc. To make cleaning and disinfecting easier, always clean and disinfect the Arthrex DrillSaw May 300 System immediately after use; do not allow bodily fields and tissue to dry on any of the system components.

  • Page 32: Preliminary Cleaning

    DrillSaw Mini 300™ System User’s Guide 1. Using a disinfecting towelette or a low-linting cloth dipped in disinfectant solution, gently wipe down all surfaces of gross contamination from the battery charger. 2. Using a second (fresh) towelette or cloth, thoroughly wet the surface of the battery pack and ensure it remains visibly wet for the contact time recommended by the disinfectant manufacturer.

  • Page 33: Automated Cleaning And Thermal Disinfection

    Arthrex during the validation of these instructions. If your washer-disinfector has an ULTRASONIC cleaning stage, you must deactivate it prior to cleaning the DrillSaw Mini 300 System handpieces. Ultrasonic cleaning of the handpiece is NOT approved, and can cause damage to the handpiece.

  • Page 34: Sterilization

    (cleared by the FDA or the local governing body). Only Arthrex devices should be included in the trays. These validated instructions are not applicable to trays that include devices not intended to be used with Arthrex trays. 6.1 Approved Sterilization Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed in the table below.

  • Page 35: Transmissible Spongiform Encephalopathy Agents

    DrillSaw Mini 300™ System User’s Guide After Sterilization: The Arthrex DrillSaw Mini 300 System should be cooled to room temperature and dry prior to use in surgery. It is recommended that dry times always be used for ensure that all electrical contacts are dry as to prevent malfunctions.

  • Page 36: Maintenance

    Recommended care and handling of the DrillSaw Mini 300 System includes proper day-to- day operation, cleaning, and sterilization which are extremely important to ensure safe and efficient operation. It is important to visually inspect the DrillSaw Mini 300 System before each use.

  • Page 37: Technical Support

    DrillSaw Mini 300™ System User’s Guide 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 38: Repair Policy

    DrillSaw Mini 300™ System User’s Guide Repair Policy Contact Arthrex for a return authorization number and instructions, prior to returning the device. DFU-0223-2 Rev. 0 Page 32...

  • Page 39: 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 40: 1 . 0 Electromagnetic Emissions

    Guidance and Manufacturer's Declaration - Electromagnetic Emissions The DrillSaw Mini 300 System is intended for use in the electromagnetic environment specified below. The customer or the user of the DrillSaw Mini 300 System should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...

  • Page 41: Table 20 Guidance And Manufacturer's Statement - Electromagnetic Immunity

    Table 20 Guidance and Manufacturer's Statement - Electromagnetic Immunity The DrillSaw Mini 300 System is intended for use in the electromagnetic environment specified below. The customer or the user of the DrillSaw Mini 300 System should ensure that it is used in such an environment.

  • Page 42: Table 21 Guidance And Manufacturer's Statement - Electromagnetic Immunity (Cont'd)

    Table 21 Guidance and Manufacturer's Statement - Electromagnetic Immunity (cont’d) The DrillSaw Mini 300 System is intended for use in the electromagnetic environment specified below. The customer or the user of the DrillSaw Mini 300 System should ensure that it is used in such an environment.
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  • Page 44: Table 22 Accessories For Drillsaw Mini 300 System

    DrillSaw Mini 300™ System User’s Guide Table 22 Accessories for DrillSaw Mini 300 System™ AR-300 Handpiece AR-300B Burr Attachment 2.35mm AR-300B-2 Drill Attachment 2.35mm AR-300DAO-1 Drill Attachment - Style AO AR-300DAO-2 Drill Attachment – Style AO AR-300DJ Drill Jacobs Chuck 0 – 0.4 mm AR-300DK30 Drill Keyless Chuck 0 –...
  • Page 45 DrillSaw Mini 300™ System User’s Guide AR-300H Elongation Handle AR-300C-G Tray for AR-300 AR-300C Instrument Case AR-300KEY Replacement Key for Jacobs Chuck for AR-300 AR-300HKEY Replacement Key for Hybrid Chuck for AR-300 AR-400UBC Universal Battery Charger AR-400UBC-3 Charging Bay for AR-300L and AR-600L, Aseptic Battery DFU-0223-2 Rev.
  • Page 46 DrillSaw Mini 300™ System User’s Guide This page intentionally left blank DFU-0223-2 Rev. 0 Page 40...
  • Page 47 DrillSaw Mini 300™ System User’s Guide This page intentionally left blank DFU-0223-2 Rev. 0 Page 41...
  • Page 48 Arthrex, Inc. 1370 Creekside Blvd. Naples, FL 34108-1945 USA www.arthrex.com Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany Tel: +49 89 909005-0 www.arthrex.de All rights reserved. 0086 DFU-0223-2 Rev. 0 Page 42...

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