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DrillSaw Sports 400™ System
User's Guide
The Arthrex DrillSaw Sports 400™ System User's Guide
provides safety operation information for all components of
the Arthrex DrillSaw Sports 400™ 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.
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-0253-4
Revision 0
06/2020
© 2020 Arthrex, Inc. All rights reserved
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Summary of Contents for Arthrex DrillSaw Sports 400 System
- Page 1 DrillSaw Sports 400™ System User’s Guide The Arthrex DrillSaw Sports 400™ System User’s Guide provides safety operation information for all components of the Arthrex DrillSaw Sports 400™ 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 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...
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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 ..........6 Product Description and Intended Use ..........7 Product Description .................... 7 Intended Use ...................... - Page 4 Table of contents Aseptic Battery Pack ..................29 Detergent Selection ..................30 Preliminary Cleaning ..................31 Handpiece, Aseptic Battery Housing, and Sterilizable Battery ......31 Attachments and Aseptic Transfer Kit ..............31 Automated Cleaning and Thermal Disinfection ..........31 Sterilization ..................34 Approved Sterilization - Handpiece, Attachments, Aseptic Battery Housing and Aseptic Transfer Kit ....................
- Page 5 Table of contents List of Figures Figure 1 Handpiece ..........................9 Figure 2 AR-400UB Aseptic Battery Pack ..................10 Figure 3 Aseptic Battery Housing ..................... 11 Figure 4 AR-400SB Sterilizable Battery ..................... 12 Figure 5 Connecting and removing an attachment ................ 17 Figure 6 Connecting a battery ......................
- Page 6 Guidance and Manufacturer's Declaration - Electromagnetic Emissions ....41 Table 22 Guidance and Manufacturer's Statement - Electromagnetic Immunity ....... 42 Table 23 Guidance and Manufacturer's Statement - Electromagnetic Immunity (cont’d) ..42 Table 24 DrillSaw Sports 400 System™ .................... 44 DFU-0253-4r0_fmt_en-US Page iv...
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Page 7: General Warnings And Safety Notices - Read This First
User’s Guide. Before using the DrillSaw Sports 400 System for the first time, store it at room temperature for 24 hours. Charge batteries before every use. Follow the instructions for charging the batteries before use. - Page 8 20. To avoid potential injury, never allow a rotary or saw attachment to make contact with the surrounding soft tissues and vessels. 21. Never use the Arthrex DrillSaw Sports 400 System in areas near strong magnetic fields. 22. Do not place the handpiece on the patient.
- Page 9 • Surgeons are advised to review the product-specific surgical technique prior to performing any surgery. Arthrex provides detailed surgical techniques in print, video, and electronic formats. The Arthrex website also provides detailed surgical technique information and demonstrations. Or, contact your Arthrex representative for an onsite demonstration.
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Page 10: Symbol Definitions
DrillSaw Sports 400™ System 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. Fragile, handle with Non sterile care Caution This side up Temperature limits for Keep dry storage and transport Electrical hazard,... - Page 11 Consult Instructions for Use • All of the symbols used on the labeling along with the title, description and standard designation number may be found on our website at www.arthrex.com/symbolsglossary. DFU-0253-4r0_fmt_en-US Page 5 of...
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Page 12: 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 13: Product Description And Intended Use
Activation of the handpiece is achieved by pressing a hand switch. Intended Use The DrillSaw Sports 400 System is a battery-driven power tool which uses a multitude of attachments for cutting, drilling, reaming, and pin and wire driving. This system is intended to be used in general orthopaedic surgical applications. - Page 14 DrillSaw Sports 400™ System User’s Guide Arthrex DrillSaw Sports 400 System parts and accessories: (See Table 24) Handpiece • Attachments • • Aseptic Battery Pack Aseptic Battery Housing (aseptic battery only) • Aseptic Transfer Kit (aseptic battery only) • Sterilizable Battery •...
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Page 15: Product Functions
DrillSaw Sports 400™ System User’s Guide Product Functions AR-400 Handpiece The handpiece functions are identified and defined below. Figure 1 Handpiece Table 1 Handpiece Collet Release button Mode switch Battery connection Safe position Forward only (Reverse is locked out) All functions: 6a –... -
Page 16: Ar-400Ub Aseptic Battery Pack
DrillSaw Sports 400™ System User’s Guide AR-400UB Aseptic Battery Pack The main elements of the AR-400UB Aseptic Battery Pack are identified and defined below. Figure 2 AR-400UB Aseptic Battery Pack Table 2 AR-400UB Aseptic Battery Pack Battery contacts Handle DFU-0253-4r0_fmt_en-US Page 10 of... -
Page 17: Ar-400Ubh-1 Aseptic Battery Housing
DrillSaw Sports 400™ System User’s Guide AR-400UBH-1 Aseptic Battery Housing The main elements of the Aseptic Battery Housing are identified and defined below. Figure 3 Aseptic Battery Housing Table 3 Aseptic Battery Housing Battery contacts Battery housing door Release tab to remove battery housing from handpiece Lever to open and close battery housing door 5a- Lever position when battery housing door closed 5b- Lever position when battery housing door open... -
Page 18: Figure 4 Ar-400Sb Sterilizable Battery
DrillSaw Sports 400™ System User’s Guide 2.5.4 AR-400SB Sterilizable Battery The main elements of the AR-400SB Sterilizable Battery are identified and defined below. Figure 4 AR-400SB Sterilizable Battery Table 4 AR-400SB Sterilizable Battery Battery contacts Release tab to remove battery from handpiece DFU-0253-4r0_fmt_en-US Page 12 of... -
Page 19: Technical Specifications
Worst Case Temperature Condition: At 40°C (104°F) 18 seconds on/off for 5 cycles, then wait 60 minutes Following the duty cycle is an important part of maintaining the Arthrex DrillSaw Sports 400 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 20: Attachments
DrillSaw Sports 400™ System User’s Guide Attachments Table 8 Attachments Drill Speed 1,330 rpm Drill Torque 3.2 Nm (28 inch pounds) Reamer Speed 330 rpm Reamer Torque 9 Nm (79 inch pounds) Cutting 23,000 cpm Sterilization DFU-0253-4r0_fmt_en-US Page 14 of... -
Page 21: Safety, Emc, And Regulatory Requirements
DrillSaw Sports 400™ System User’s Guide Safety, EMC, and Regulatory Requirements Table 9 Safety, EMC, and Regulatory Requirements Parameter Parameter Value Class I System Classification IEC 60601-1 (protection against electric shock) FDA class Class I EU class Class IIa Health Canada Class Class II Safety Certifications Domestic Certification... -
Page 22: Electromagnetic Compatibility (Emc)
Arthrex. The DrillSaw Sports 400 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 23: Setup
DrillSaw Sports 400™ 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 and removing an attachment to the AR-400 handpiece. -
Page 24: Setup - Connecting A Battery To The Handpiece
DrillSaw Sports 400™ System User’s Guide 4.3 Setup - Connecting a Battery to the Handpiece These instructions describe the procedure for connecting a battery to the AR-400 handpiece. Figure 6 Connecting a battery Table 11 Connecting a battery Align the rails on top of the battery with the bottom of the handpiece Slide the battery on to the handpiece until is snaps into place. -
Page 25: Setup - Removing A Battery From The Handpiece
DrillSaw Sports 400™ System User’s Guide 4.4 Setup - Removing a battery from the Handpiece These instructions describe the procedure for removing a battery from the AR-400 handpiece. Figure 7 Removing a battery Table 12 Removing a battery Press down on the battery release tab and hold. Move the handpiece away from the battery along the rails. -
Page 26: Setup - Quick Connect Of Drilling And Reaming Attachments
DrillSaw Sports 400™ System User’s Guide 4.5 Setup - Quick Connect of Drilling and Reaming Attachments These instructions describe the procedure for inserting a drill bit into the AR-400 quick connect attachments. Insert a drill bit Figure 8 Insert a drill bit Table 13 Pull back on the quick connect collar and hold it in place. -
Page 27: Setup - Drilling And Reaming Attachments, Keyed Jacobs Chuck
DrillSaw Sports 400™ 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-400 keyed chucks. Insert a drill bit into a Jacobs Chuck Figure 9 Insert a drill bit into a Jacobs Chuck Table 14 Open the collar of the Jacobs Chuck enough for the drill bit to fit... -
Page 28: Setup - Drilling And Reaming Attachments, Keyless Chuck
DrillSaw Sports 400™ System User’s Guide 4.7 Setup - Drilling and Reaming Attachments, Keyless Chuck These instructions describe the procedure for inserting a drill bit to the AR-400 keyless attachments. Insert a drill bit into a Keyless Chuck Figure 10 Insert a drill bit into a Keyless Chuck Table 15 Open the collar of the Chuck enough for the drill bit to fit into the... -
Page 29: Setup - Sagittal Saw Attachment
DrillSaw Sports 400™ System User’s Guide 4.8 Setup - Sagittal Saw Attachment These instructions describe the procedure for inserting a sawblade to the AR-400 sagittal saw attachment. Insert a sawblade Figure 11 Insert a sawblade Table 16 Press the button on top of the attachment to open the collet. Align the blade hub with the pins inside the collet and release the button to retain the blade. -
Page 30: Figure 12 Indexing The Saw Head
DrillSaw Sports 400™ System User’s Guide These instructions describe the procedure for indexing the head of the sagittal saw attachment. The sagittal saw attachment can be indexed in 45° increments or 8 positions in 360 degrees. Indexing the saw head Figure 12 Indexing the saw head Table 17... -
Page 31: Setup - Burr And J-Latch Attachments
DrillSaw Sports 400™ System User’s Guide 4.9 Setup – Burr and J-Latch Attachments These instructions describe the procedure for inserting a rotary instrument into the AR-400B burr and AR-400JLD j-latch attachments. Inserting a rotary instrument (burr/drill bit) Figure 13 Inserting a rotary instrument (burr/drill bit) Table 18 Twist the attachment collet-lock to the unlocked (open) position Insert the rotary instrument , ensuring instrument is fully seated... -
Page 32: Setup - Wire/Pin Driver Attachment
DrillSaw Sports 400™ System User’s Guide Setup - Wire/Pin Driver Attachment These instructions describe the procedure for inserting a pin to the AR-400 pin driver attachment. Inserting a wire /pin Figure 14 1 & 2 Inserting a wire/pin Table 19 Press the wire/ pin into the retaining mechanism at the opening of the attachment. -
Page 33: Aseptic Battery Housing/Aseptic Battery Pack/Aseptic Transfer Kit
DrillSaw Sports 400™ System User’s Guide Aseptic Battery Housing/Aseptic Battery Pack/Aseptic Transfer Kit These instructions describe the procedure for transferring the aseptic battery pack into the aseptic battery housing, using the aseptic transfer kit. Aseptic Battery Pack Transfer Figure 15 Aseptic Battery Pack Transfer Table 20 Sterile Technician... - Page 34 DrillSaw Sports 400™ System User’s Guide 3a - The assembled battery is now ready to be placed on the handpiece. DFU-0253-4r0_fmt_en-US Page 28 of...
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Page 35: 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 Sports 400 System immediately after use; do not allow bodily fields and tissue to dry on any of the system components. -
Page 36: Detergent Selection
Transmissible Spongiform Encephalopathy (TSE) or Creutzfeldt - Jakob disease (CJD) are a concern (applies only outside of the US). Arthrex does not recommend the use of a specific brand of cleaning agent. Enzol... -
Page 37: Preliminary Cleaning
Ensure that items such as the aseptic battery housing are open and point downward so that they do not retain water. If using an Arthrex wash tray specifically designed for use with an automated washer/disinfector, load the devices in their respective positions in the tray. - Page 38 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 Sports 400 System handpiece. Ultrasonic cleaning of the handpiece is NOT approved and can cause damage to the handpiece.
- Page 39 DrillSaw Sports 400™ System User’s Guide 5. Remove the devices from the washer-disinfector following the completion of the program and check devices for visible soil. Repeat cleaning if soil is visible and re- inspect; otherwise, proceed to Sterilization section. DFU-0253-4r0_fmt_en-US Page 33 of...
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Page 40: 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 - Handpiece, Attachments, Aseptic... -
Page 41: Approved Sterilization - Sterilizable Battery
Do not sterilize battery pack while attached to handpiece! After Sterilization: The Arthrex DrillSaw Sports 400 System should be cooled to room temperature and dry prior to use in surgery. It is recommended that dry times always be used to ensure all electrical contacts are dry as to prevent malfunctions. -
Page 42: Transmissible Spongiform Encephalopathy Agents
DrillSaw Sports 400™ System User’s Guide W A R N I N G ! After autoclaving, the accessory devices are VERY HOT. Handle with care to avoid burns. 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 43: Maintenance
Recommended care and handling of the DrillSaw Sports 400 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 Sports 400 System before each use. -
Page 44: Technical Support
DrillSaw Sports 400™ 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 45: Repair Policy
DrillSaw Sports 400™ System User’s Guide Repair Policy Contact Arthrex for a return authorization number and instructions, prior to returning the device. DFU-0253-4r0_fmt_en-US Page 39 of... -
Page 46: 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 47: 1 . 0 Electromagnetic Emissions
Guidance and Manufacturer's Declaration - Electromagnetic Emissions The DrillSaw Sports 400 System is intended for use in the electromagnetic environment specified below. The customer or the user of the DrillSaw Sports 400 System should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –... -
Page 48: Table 22 Guidance And Manufacturer's Statement - Electromagnetic Immunity
Table 22 Guidance and Manufacturer's Statement - Electromagnetic Immunity The DrillSaw Sports 400 System is intended for use in the electromagnetic environment specified below. The customer or the user of the DrillSaw Sports 400 System should ensure that it is used in such an environment. - Page 49 DrillSaw Sports 400™ System User’s Guide Immunity IEC 60601 Compliance Electromagnetic environment - guidance test test level level should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: Proximity 9 V/m to 28 9 V/m to 28...
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Page 50: Table 24 Drillsaw Sports 400 System
DrillSaw Sports 400™ System User’s Guide Table 24 DrillSaw Sports 400 System™ Handpiece AR-400 Handpiece Attachments AR-400DAO Small AO Drill Attachment AR-400DZH Zimmer/Hudson Drill Attachment AR-400DJ40 0 – 4.0 mm Jacobs Chuck Drill Attachment, Keyed AR-400DJ74 0 – 7.4 mm Jacobs Chuck Drill Attachment, Keyed AR-400DK74 0.6 –... - Page 51 DrillSaw Sports 400™ System User’s Guide AR-400B 2.35 mm Burr Attachment AR-400JLD 2.35 mm J-latch Attachment Aseptic Battery System AR-400UB Aseptic Battery Pack for AR-400UBH-1 AR-400UBH-1 Aseptic Battery Housing for AR-400UB AR-400ATK-1 Aseptic Transfer Kit for AR-400UB Sterilizable Battery AR-400SB Sterilizable Battery Charger and Charging Bays AR-400UBC...
- Page 52 DrillSaw Sports 400™ System 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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Hi. Should I oil the Arthrex drill and attachments. If so, could you send me info. Thank you.