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AR-400
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. 2797 Arthrex, Inc. 1370 Creekside Blvd. Naples, FL 34108-1945 USA Toll Free: 1-(800) 934-4404 www.arthrex.com www.arthrex.com/dfu-list EC REP Arthrex GmbH Erwin-Hielscher-Strasse 9 81249 München, Germany Tel: +49 89 909005-0 Fax: +49 89 909005-280 www.arthrex.de DFU-0253-5 Revision 0 04/2021 © 2021 Arthrex, Inc. All rights reserved
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.
Table of contents 1.0 General Warnings and Safety Notices - Read This First .................... 1 Important Safety Conventions ............................................................................ 1 Symbol Definitions ............................................................................................. 4 Shipping, Unpacking, and Warranty Information ................................................ 6 2.0 Product Description and Intended Use ............................................... 7 Product Description ............................................................................................ 7 Intended Use...................................................................................................... 7 Contraindications ............................................................................................... 7 Set Composition ................................................................................................. 8 Product Functions .............................................................................................. 9 2.5.1 AR-400 Handpiece .................................................................................................. 9 2.5.2 AR-400UB Aseptic Battery Pack ........................................................................... 10 2.5.3 AR-400UBH-1 Aseptic Battery Housing ................................................................ 11 2.5.4 AR-400SB Sterilizable Battery .............................................................................. 12 3.0 Technical Specifications ................................................................... 13 Handpiece ........................................................................................................ 13 Attachments ..................................................................................................... 14 Safety, EMC, and Regulatory Requirements.................................................... 15 3.4 Electromagnetic Compatibility (EMC)............................................................... 16 3.5 Risks due to electromagnetic fields: ................................................................. 16 4.0 Setup ................................................................................................ 17 4.1 How to Set Up the Handpiece .......................................................................... 17 4.2 Setup - Connecting and Removing an Attachment to the Handpiece .............. 17 4.3 Setup - Connecting a Battery to the Handpiece ............................................... 18 4.4 Setup - Removing a battery from the Handpiece ............................................. 19 4.5 Setup - Quick Connect of Drilling and Reaming Attachments .......................... 20 4.6 Setup - Drilling and Reaming Attachments, Keyed Jacobs Chuck ................... 21 4.7 Setup - Drilling and Reaming Attachments, Keyless Chuck ............................. 22 4.8 Setup - Sagittal Saw Attachment...................................................................... 23 4.9 Setup – Burr and J-Latch Attachments ............................................................ 25 Setup - Wire/Pin Driver Attachment ................................................................. 26 Aseptic Battery Housing/Aseptic Battery Pack/Aseptic Transfer Kit ................. 27
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Table of contents 5.0 Cleaning ........................................................................................... 28 5.1 Aseptic Battery Pack Cleaning and Disinfection............................................... 28 5.2 Detergent Selection.......................................................................................... 29 5.3 Preliminary Cleaning ........................................................................................ 30 5.3.1 Handpiece, Aseptic Battery Housing, Instrument Case, and Sterilizable Battery..30 5.3.2 Attachments and Aseptic Transfer Kit ................................................................... 30 5.4 Automated Cleaning......................................................................................... 31 5.4.1 Automated Wash Cycle for Handpiece, Attachments, Aseptic Battery Housing, Aseptic Transfer Kit, and Instrument Trays/Cases .............................................................. 31 5.4.2 Automated Wash Cycle for Sterilizable Battery.....................................................32 6.0 Sterilization ....................................................................................... 34 6.1 Approved Sterilization - Handpiece, Attachments, Aseptic Battery Housing and Aseptic Transfer Kit (Single Devices or Sets) ............................................................ 34 6.2 Approved Sterilization – Sterilizable Battery ONLY .......................................... 35 Transmissible Spongiform Encephalopathy Agents ......................................... 36 7.0 Maintenance ..................................................................................... 37 Periodic Maintenance....................................................................................... 37 8.0 Technical Support ............................................................................. 38 Additional Technical Information ...................................................................... 38 9.0 Repair Policy.....................................................................................39 10.0 End of Life, Environmental Directives ............................................... 40 Specific guidelines for the disposal of Li-Ion batteries...................................... 40 11.0 Electromagnetic Emissions...............................................................41
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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 .......................................................................................................... 18 Figure 7 Removing a battery............................................................................................................. 19 Figure 8 Insert a drill bit ..................................................................................................................... 20 Figure 9 Insert a drill bit into a Jacobs Chuck ................................................................................ 21 Figure 10 Insert a drill bit into a Keyless Chuck ............................................................................... 22 Figure 11 Insert a sawblade ................................................................................................................ 23 Figure 12 Indexing the saw head ....................................................................................................... 24 Figure 13 Inserting a rotary instrument (burr/drill bit) ...................................................................... 25 Figure 14 Inserting a wire /pin............................................................................................................. 26 Figure 15 Aseptic Battery Pack Transfer........................................................................................... 27
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Table of contents List of Tables Table 1 Handpiece ............................................................................................................................... 9 Table 2 AR-400UB Aseptic Battery Pack........................................................................................ 10 Table 3 Aseptic Battery Housing ...................................................................................................... 11 Table 4 AR-400SB Sterilizable Battery ........................................................................................... 12 Table 5 Handpiece AR-400 ............................................................................................................... 13 Table 6 Ambient conditions for operation ....................................................................................... 13 Table 7 Ambient conditions for storage (in shipping packaging)................................................. 13 Table 8 Attachments .......................................................................................................................... 14 Table 9 Safety, EMC, and Regulatory Requirements ................................................................... 15 Table 10 Connecting and removing an attachment......................................................................... 17 Table 11 Connecting a battery............................................................................................................ 18 Table 12 Removing a battery .............................................................................................................. 19 Table 13 Insert a drill bit....................................................................................................................... 20 Table 14 Insert a drill bit into a Jacobs Chuck.................................................................................. 21 Table 15 Insert a drill bit into a Keyless Chuck ................................................................................ 22 Table 16 Insert a sawblade ................................................................................................................. 23 Table 17 Indexing the saw head......................................................................................................... 24 Table 18 Inserting a rotary instrument (burr/drill bit)........................................................................ 25 Table 19 Inserting a wire/pin ............................................................................................................... 26 Table 20 Aseptic Battery Pack Transfer............................................................................................ 27 Table 21 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
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DrillSaw Sports 400™ System User’s Guide 1.0 General Warnings and Safety Notices - Read This First It is imperative that the symbols and conventions listed below be clearly understood. The DrillSaw Sports 400 System User’s Guide identifies critical, important, and useful information using these symbols and conventions. Important Safety Conventions Users of this device are encouraged to contact their Arthrex representative if they require a more comprehensive surgical technique. WARNING! The WARNING! label is the most important safety symbol. It identifies critical information that must be followed precisely to avoid injury or death. 1. Use this device only for purposes described in the User’s Guide, under the supervision of a trained and licensed physician. This device should not be used by untrained personnel or used for indications other than those described in this User’s Guide. 2. Before using the DrillSaw Sports 400 System for the first time, store it at room temperature for 24 hours. 3. Charge batteries before every use. Follow the instructions for charging the batteries before use. 4. The device is intended to apply mechanical force/rotational energy to the patient. 5. Before each use, check the handpiece and the attachments for damage and/or loose parts. Do not use any part that is damaged. 6. Prior to each use, fully assemble the system and press the trigger mechanism to ensure proper function. All couplings and mechanical connections need to be fully secured or locked before the actuation of the system. Never touch the chuck mechanism of the handpiece while the motor is still in motion. 7. Avoid overheating at the treatment site by following the duty cycle and using sharp cutting and drilling accessories. 8. No modification of the AR-400 or the accessories is allowed. 9. Unauthorized attempts to open or service this system will void the warranty. Removing the cover may introduce an electric shock hazard by exposing the user to dangerously high voltages or other risks. If the system malfunctions, it should be returned for service immediately. 10. Misuse, unauthorized assembly and modifications or repairs to the AR-400 system, or non-compliance with these instructions relieves Arthrex of all liability for claims under warranty or other claims.
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DrillSaw Sports 400™ System User’s Guide 11. 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 injury to the patient and/or operating room staff. 12. Do not use in the presence of flammable anesthetics or oxidizing gases such as nitrous oxide, oxygen, or endogenous gases. All oxygen connections must be leak free for the duration of the surgical procedure. 13. After autoclaving, the accessory devices are VERY HOT. Handle with care to avoid burns. 14. The equipment is NOT suitable for use in potentially explosive atmospheres or with potentially explosive mixtures of anesthetic substances containing oxygen or nitrous oxide. 15. Zone M is defined as a “medical environment” and constitutes the part of a room in which potentially explosive atmospheres may form due to the use of anesthetics or medical antiseptics and antibacterial soaps; such atmospheres are typically localized and temporary. Zone M comprises a truncated pyramid below the operating table which is tilted outwards at a 30° angle. 16. Zone G, also known as an “enclosed medical gas system”, does not necessarily include areas enclosed around all sides, in which explosive mixtures are continuously or temporarily generated, directed or used in small quantities. 17. Only fit an attachment/accessory when the handpiece is at a complete stop and in safe position. Safe position is annotated by the “S” on the mode switch. 18. Do not interfere with the rotary instruments or saws while they are in motion. 19. Never touch an attachment or press the release mechanism of the collet while the device is in motion. 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. 23. Disconnect the rechargeable battery immediately after using the handpiece. 24. Only use accessories which are in proper working order. Damaged or improperly functioning accessories must be sent in for service. 25. It is recommended to have a backup system available should the need arise. 26. For Aseptic Battery Pack (AR-400UB) and Sterilizable Battery (AR-400SB): Warning: Risk of Fire, Burns and Explosion. Do Not Short Circuit, Open, Crush or Incinerate
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DrillSaw Sports 400™ System User’s Guide The PRECAUTION! symbol identifies methods and procedures that must be followed to avoid damaging the device or causing it to malfunction. 1. DO NOT – under any condition, or for any reason – open the handpiece, any system component, or any other system accessory. 2. 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. 3. Do not attach accessories to the handpiece unless the handpiece is in the safe mode. 4. Only use batteries approved by Arthrex. 5. Do NOT clean the device with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch or damage the device. 6. The aseptic battery packs are NOT to be cleaned and disinfected in a washer- disinfector. 7. NEVER place the handpiece or accessories in Cidex or other aldehyde disinfectant solutions. 8. After sterilization in the autoclave, let the accessory device cool down slowly. NEVER use cold water to cool the handpieces. This will damage the electronic components and seals. 9. Liquid on the battery and handpiece contacts may damage the device. Before connecting the battery, ensure the receptacles are clean and dry. 10. Always comply with the instructions issued by the manufacturer of the cleaning agent or disinfectant regarding concentration, exposure times, temperature, and material compatibility. 11. Remove all accessories, including attachments and battery before sterilizing a handpiece. 12. Caution: Federal law restricts this device to sale by or on the order of a physician. 13. This device is intended to be used by a trained medical professional 14. Biohazard waste, such as explanted devices, needles and contaminated surgical equipment, should be safely disposed of in accordance with the institutions policy. 15. Serious incidents should be reported to Arthrex Inc., or an in-country representative, and to the health authority where the incident occurred. 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. In CE accepting Countries: Procedures carried out using these devices may be used on the general population.
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DrillSaw Sports 400™ System User’s Guide In CE accepting Countries: The clinical benefits associated with the use of these devices outweigh the known clinical risks. In CE accepting Countries: There are no unacceptable residual risks or uncertainties associated with the clinical use of these devices.
Symbol Definitions Safety Sign Follow operating instructions
NON STERILE
Non sterile
Caution: Federal law restricts this device to sale by or on the order of a physician. Fragile, handle with care
Caution
This side up
Keep dry
Electrical hazard, dangerous voltages are present. Never attempt to repair the equipment. Only trained service personnel may remove the cover, or obtain access to system components.
EC REP
Authorized representative in the European Community
SN
Serial number
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Temperature limits for storage and transport Atmospheric pressure limitation for storage and transport Humidity limits for storage and transport Manufacturer Page 4 of 46
DrillSaw Sports 400™ System User’s Guide
Electrical waste
REF
Catalog number
2797
Date of manufacture; year and month. The product meets the essential requirements of Medical Device Directive 93/42/EEC
QTY
Quantity
Do not use if package is damaged
Type B Device – Not suitable for intracardiac applications
RF symbol. Nonionizing electromagnetic radiation
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.
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DrillSaw Sports 400™ System User’s Guide 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. Please visit Arthrex.com for warranty information.
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DrillSaw Sports 400™ System User’s Guide 2.0 Product Description and Intended Use Product Description The Arthrex DrillSaw Sports 400 System is a battery powered surgical instrument. The handpiece contains a microprocessor and is powered by a Lithium Ion battery. 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. Contraindications The DrillSaw Sports 400 System is contraindicated in any non-orthopedic surgery procedure and procedure disregarding the intended use. Specifically: use by unskilled/untrained personnel disregarding the intended use non-compliance with the operation mode usage of improper accessories use on spinal or neuro procedures Only use Arthrex accessories. WARNING! Misuse may damage the DrillSaw Sports 400 System and cause risks and hazards for patients, users and third parties. WARNING! This device is only for use under the supervision of a trained and licensed physician. This device should not be used by untrained personnel or used for indications other than those described in this User’s Guide.
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Set Composition
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 Universal Battery Charger (see DFU-0256-XX) Charging Bays Instrument Case
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DrillSaw Sports 400™ System User’s Guide
Product Functions
2.5.1 AR-400 Handpiece
The handpiece functions are identified and defined below.
Figure 1
Handpiece
4
1
5
6a
2
6
6b
3
6c
Table 1 1. 2. 3. 4. 5. 6.
Handpiece Collet Release button Mode switch Battery connection Safe position Forward only (Reverse is locked out) All functions: 6a – Forward 6b – Reverse 6c - Oscillate
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DrillSaw Sports 400™ System User’s Guide
2.5.2 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
1
2
Table 2 1. 2.
AR-400UB Aseptic Battery Pack Battery contacts Handle
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DrillSaw Sports 400™ System User’s Guide
2.5.3 AR-400UBH-1 Aseptic Battery Housing
The main elements of the Aseptic Battery Housing are identified and defined below.
Figure 3
Aseptic Battery Housing
3 1 4 2
5a
5b
Table 3 1. 2. 3. 4. 5.
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
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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
1
2
Table 4 1. 2.
AR-400SB Sterilizable Battery Battery contacts Release tab to remove battery from handpiece
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3.0
DrillSaw Sports 400™ System User’s Guide
Technical Specifications
Handpiece
Table 5
Handpiece AR-400
Width Height Depth Weight Cannulation Protection Speed Torque Applied part type Pollution level Overvoltage category Altitude Duty Cycle*
40 mm (1.574”) 141.5 mm (5.57”) 121mm (4.764”) 630 g (1.3 lbs.) 3.2 mm (0.126”) IPX0 for Handpiece and IPX4 for AR-400UBH-1 See Section 3.2 Table 7 Attachments See Section 3.2 Table 7 Attachments B 2 II Up to 3,000 m [9,842 ft.] above sea level Operating Type S3 per IEC 60034-1 At 25°C (77° F) Ambient Temperature: 30 seconds on/off for 5 cycles, then wait 48 minutes 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° C (77° F). Operating the device above of these prescribed parameters can lead to user and patient injury, as well as a shortened life span of the device itself. The recommended environmental operating temperature is 25° C (77° F) or lower. Operating in environments above 25° C (77° F) can shorten the above prescribed duty cycles. The environment temperature, surgical attachment type and time need to be considered by the user, when planning its use in surgical interventions. Additionally, please read the General Warnings and Safety Notices that start on Page 1 of this User’s Guide.
Table 6
Ambient conditions for operation
Temperature Relative Humidity
10° to 40 °C (50° to 104 °F) 15% to 80% (relative), non-condensing
Table 7
Ambient conditions for storage (in shipping packaging)
Temperature Relative Humidity
-40° to +70°C (-40° to +158°F) 8% to 80% (relative), non-condensing
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DrillSaw Sports 400™ System User’s Guide
Attachments
Table 8
Attachments
Drill Speed Drill Torque Reamer Speed Reamer Torque Cutting Burring Sterilization
1,330 rpm 3.2 Nm (28 inch pounds) 330 rpm 9 Nm (79 inch pounds) 23,000 cpm 21,300 rpm (AR-400B) and 5,300 rpm (AR-400 JLD) YES
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DrillSaw Sports 400™ System User’s Guide
Safety, EMC, and Regulatory Requirements
Table 9
Safety, EMC, and Regulatory Requirements
Parameter System Classification
Parameter Value IEC 60601-1
Safety Certifications
FDA class EU class Health Canada Class Domestic Certification
Canadian Certification
EU Certification
EMC Certifications
EMC Certification
Safety Certification Marking UL
Class I (protection against electric shock) Class I Class IIa Class II ANSI/AAMI ES60601-1 (2005+C2+A2) CSA C22.2 No 60601.1 (2008) EN/IEC 60601-1 3rd ed. + Amendment 1 EN 60601-1-2 4th
CE Classification MDD 93/42/EEC
Annex IX Rule 9
Class IIa
For all other accessories refer to accompanying DFUs for more information. Refer to Section 11.0 Electromagnetic Emissions for further details on EMC certification.
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DrillSaw Sports 400™ System User’s Guide 3.4 Electromagnetic Compatibility (EMC) 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. 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: 1. Reorient or relocate the receiving device. 2. Increase the distance between the devices. 3. Connect the device to an outlet on a different circuit than the other device(s) are connected to. 4. Consult the manufacturer or field service technician for the receiving device for guidance. 3.5 Risks due to electromagnetic fields: The functionality of implantable systems, such as cardiac pacemakers and ICD (implantable cardioverter defibrillator) can be affected by electric, magnetic and electromagnetic fields. 1. Consider the application and find out if patient or user has any of these devices, before using the product. 2. Weigh the risks and benefits. 3. Keep the product away from any of these devices. 4. Make appropriate emergency provisions and take immediate action upon any signs of health issues. 5. Symptoms such as raised heartbeat, irregular pulse and dizziness can be signs of a problem with a cardiac pacemaker or ICD.
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DrillSaw Sports 400™ System User’s Guide 4.0 Setup 4.1 How to Set Up the Handpiece Users are encouraged to contact their Arthrex representative if they require a more comprehensive surgical technique.
4.2 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.
Figure 5
Connecting and removing an attachment
2 1 2
Table 10 1. 2.
Connecting and removing an attachment Insert the attachment until it snaps into place. To remove the attachment: - Press the collet release button and hold - Pull the attachment away from the handpiece
WARNING! Always ensure that the handpiece is in safe mode when connecting and disconnecting attachments and accessories.
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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
2 3 1
Table 11 1. 2. 3.
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. An audible click will be heard once the battery is fully engaged with the handpiece. The battery is fully connected.
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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
1 2
Table 12 1. 2.
Removing a battery Press down on the battery release tab and hold. Move the handpiece away from the battery along the rails.
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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.
Figure 8
Insert a drill bit
1 3 2
Table 13 1. 2. 3.
Insert a drill bit Pull back on the quick connect collar and hold it in place. Insert the drill bit into the end of the attachment. Release the collar and check to make sure the drill bit is secured in the attachment.
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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.
Figure 9
Insert a drill bit into a Jacobs Chuck
1
2
Table 14 1. 2.
Insert a drill bit into a Jacobs Chuck Open the collar of the Jacobs Chuck enough for the drill bit to fit into the attachment. Insert the drill bit. Use the chuck key to tighten down the collar. Make sure to tighten using all three holes on the Jacobs Chuck.
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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.
Figure 10
Insert a drill bit into a Keyless Chuck
2
1
Table 15 1. 2.
Insert a drill bit into a Keyless Chuck Open the collar of the Chuck enough for the drill bit to fit into the attachment. Insert the drill bit. Hold the locking collar with one hand and twist the distal end of the chuck with your other hand, until the drill bit is firmly held in place.
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DrillSaw Sports 400™ System User’s Guide
4.8 Setup - Sagittal Saw Attachment
These instructions describe the procedure for inserting a sawblade into the AR-400 sagittal saw attachment.
Figure 11
Insert a sawblade
1
2
Table 16 1. 2.
Insert a sawblade 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. - Pull on the blade to ensure it is fully seated in the attachment.
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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.
Figure 12
Indexing the saw head
1 2
Table 17 1. 2.
Indexing the saw head With the sagittal saw attachment affixed to the handpiece, grasp the very end of the sagittal saw with your thumb and forefinger. Then pull the attachment away from the handpiece. - This will release the locking mechanism and allow you to rotate the saw head either left or right. Picture 2 in Figure 12 shows the sagittal saw head being turned counterclockwise. Turn the saw head to the desired position and release it so that it locks back in place.
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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.
Figure 13
Inserting a rotary instrument (burr/drill bit)
1
2
3 Attachment above shown in a locked (Closed Position)
Warning: All couplings and mechanical connections need to be fully secured or locked before the actuation of the system.
Table 18 1. 2.
Inserting a rotary instrument (burr/drill bit) Twist the attachment collet-lock to the unlocked (open) position Insert the rotary instrument, ensuring instrument is fully seated
3.
Twist the collet-lock to the locked (closed) position and check that
the connection is secure by pulling on the rotary instrument in an
axial direction.
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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.
Figure 14
Inserting a wire /pin
1 & 2
3
Table 19 1. 2. 3.
Inserting a wire/pin Press the wire/ pin into the retaining mechanism at the opening of the attachment. Slide the wire/pin into the driver until the desired length is reached. Press the lever to hold the wire/pin in place while driving the wire/pin. - Positive tension from the lever and retaining mechanism will hold wire/pin in place when the instrument is handed to the surgeon.
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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.
Figure 15
Aseptic Battery Pack Transfer
1
2
B
3 B
A A A 3a
Table 20 A
Aseptic Battery Pack Transfer Sterile Technician
B
Non-sterile Circulating Nurse
1.
The Sterile Technician holds the aseptic battery housing (sterile)
upright and places the aseptic transfer kit (sterile) on top.
2.
The Non-sterile Circulating Nurse places the aseptic battery pack (non-
sterile) down into the aseptic battery housing (sterile) through the
aseptic transfer kit (sterile) until the aseptic battery pack is fully seated.
3.
The Non-sterile Circulating Nurse then removes the aseptic transfer
kit, and the Sterile Technician closes the sterile battery housing door.
3a - The assembled battery is now ready to be placed on the handpiece.
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DrillSaw Sports 400™ System User’s Guide 5.0 Cleaning The handpiece, attachments, aseptic battery housing, aseptic transfer kit, instrument case, and sterilizable battery are supplied non-sterile and must be adequately cleaned, and sterilized prior to use or re-use. Follow your country-specific directives, standards and guidelines for cleaning and sterilization. Always wear proper PPE (Personal Protective Equipment) such as: gloves, eye protection, face shields, gowns, etc. To make cleaning easier, always clean the Arthrex DrillSaw Sports 400 System as soon as practicable after use; do not allow bodily fields and tissue to dry on any of the system components. With the exception of the aseptic battery pack and charging unit, Arthrex recommends processing system components (handpiece, attachments, aseptic transfer kit, aseptic battery housing, instrument case, and sterilizable battery) with an automated procedure using a washer/disinfector. Remove any attachment and battery from the handpiece prior to cleaning. Before charging the sterilizable battery, physically inspect the battery for damage and any visible contamination. Remove the aseptic battery pack from the aseptic battery housing, and clean and disinfect the battery pack according to the instructions in Section 5.1. Insert clean and dry battery onto charger and allow charging to full charge state. Batteries should be stored on charger until immediately before the sterilization process. Submerging a battery can cause damage. Do not submerge battery. Do NOT autoclave the aseptic battery pack, or put it through the Washer/Disinfector. 5.1 Aseptic Battery Pack Cleaning and Disinfection Do NOT autoclave the aseptic battery pack. It must be cleaned and disinfected after use. Do not immerse the aseptic battery pack or place it under running water as damage to the components may occur. Do not use disinfectants that contain chlorine or protein fixing effects. Use only those cleaners/disinfecting agents that are certified by your facility.
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DrillSaw Sports 400™ System User’s Guide Aseptic battery packs should be disinfected when they are not on the charging station. Avoid any pooling of cleaning/disinfectant solution in the battery contact areas. 1. Using a disinfecting towelette or a low-linting cloth dipped in disinfectant solution, gently wipe down all surfaces of gross contamination. 2. Using a second (fresh) towelette or cloth, thoroughly wet the surface of the aseptic battery pack and ensure it remains visibly wet for the contact time recommended by the disinfectant manufacturer. The use of additional towelettes or cloths may be used to ensure the surface remains visibly wet for the entire contact time. 3. If required by the disinfectant manufacturer, rinse per instructions; otherwise, allow to air dry. 4. Inspect for visual cleanliness and ensure there is no remaining gross contamination. If gross contamination remains, repeat the procedure and reinspect. For the care of the Battery Charger, see DFU-0256-XX. The aseptic battery pack must not be cleaned and disinfected in a washer/disinfector. 5.2 Detergent Selection Consider the following points during selection of the cleaning detergent: 1. Suitability of the cleaning agent for ultrasonic cleaning (no foam development), where applicable. 2. Compatibility of the cleaning agent with the instruments. Arthrex recommends the use of neutral pH or enzymatic cleaning agents. Alkaline agents may be used to clean devices in countries where required by law or local ordinance, or where prion diseases such as 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® and neodisher® MediClean forte were utilized during the validation of these instructions. Do NOT use abrasive cleaning or disinfecting compounds, solvents, or other materials that could scratch or damage the device. 3. Caution: Highly acidic or highly alkaline (>pH 10.8) solutions are not recommended, as they corrode metal parts and anodized aluminum and compromise plastics. If non-neutral pH solutions are used, make sure appropriate rinsing (as validated by the end-user facility) and neutralization
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DrillSaw Sports 400™ System User’s Guide steps are taken so they do not negatively impact the fit, finish, or function of the device. 4. Pay attention to the instructions of the detergent manufacturer with respect to neutralization and post-rinsing. 5. Follow the instructions of the detergent manufacturer regarding use concentration and temperature for either preliminary or automated cleaning. Use only freshly prepared solutions as well as only purified/highly purified water at least for final rinse, and a soft, low-linting cloth and/or filtered medical grade air for drying, respectively. 5.3 Preliminary Cleaning Preliminary cleaning of the handpiece, attachments, aseptic transfer kit, aseptic battery housing, instrument case, and sterilizable battery prior to automated cleaning is important to ensure that cannulations and other difficult-to-access areas are clean. 5.3.1 Handpiece, Aseptic Battery Housing, Instrument Case, and Sterilizable Battery 1. Prepare a detergent solution using cool utility (tap) water according to the manufacturer’s recommended concentration. 2. Using a soft-bristled brush or cloth that has been dampened with the detergent solution, remove all visible gross soil from the surface of the device. For handpieces, use an appropriately sized lumen brush that has been dampened with the same detergent solution to brush the interior of the handpiece lumen. 3. For handpieces, use an appropriately sized syringe to flush the lumens with the detergent solution until the solution flows clean. 4. Proceed to Section 5.4. 5.3.2 Attachments and Aseptic Transfer Kit 1. Rinse devices under cool utility (tap) water to remove gross soil. 2. Prepare a detergent solution using cool utility (tap) water according to the manufacturer’s recommended concentration in an ultrasonic bath. 3. Use an appropriately sized lumen brush that has been dampened with the detergent solution to brush the interior of the lumen. 4. Use an appropriately sized syringe to flush the lumens with the detergent solution until the solution flows clean. 5. Fully immerse the devices in the ultrasonic bath solution and allow to soak and sonicate for a minimum of 10 minutes. 6. Remove the devices from the solution and proceed to Section 5.4.
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DrillSaw Sports 400™ System User’s Guide 5.4 Automated Cleaning 1. After preliminary cleaning is complete, load the devices in the washer-disinfector such that all design features of the device are accessible to cleaning and such that cannulated and recessed parts will drain accordingly during the wash cycle (upright position). 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 (AR-400AC-1), load the devices in their respective positions in the tray. 2. During the automated cleaning process the Sterilizable Battery AR-400SB must be properly seated in the below orientation, with the battery release tab pointing down toward base of tray.
3. If using alkaline cleaning agents that require neutralization, a neutralization step should be utilized as appropriate. 4. Run an automated wash cycle with fundamentally approved efficiency of the washer-disinfector (for example, CE marking according to EN ISO 15883 or FDA approval/clearance/registration). The following minimum recommended wash cycle parameters were utilized by 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. 5.4.1 Automated Wash Cycle for Handpiece, Attachments, Aseptic Battery Housing, Aseptic Transfer Kit, and Instrument Trays/Cases
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DrillSaw Sports 400™ System User’s Guide
Phase
RECOMMENDED WASHING CYCLE PARAMETERS
Recirculation Time
Temperature
Detergent
Pre-Wash Cleaning Wash
3 Minutes 10 Minutes
Rinse 1
3 Minutes
Rinse 2 Thermal Disinfection Rinse Drying
3 Minutes 5 Minutes Minimum 6 Minutes or until visibly dry
Cold Water Follow detergent manufacturer’s recommendation Follow detergent manufacturer’s recommendation Cold Water 194°F (90°C) Minimum 239°F (115°C)
N/A Enzymatic or alkaline detergent Neutralizing agent (as needed) N/A N/A N/A
5.4.2 Automated Wash Cycle for Sterilizable Battery
Phase
RECOMMENDED WASHING CYCLE PARAMETERS
Recirculation Time
Temperature
Detergent
Pre-Wash Cleaning Wash Rinse 1 Rinse 2 Thermal Rinse
3 Minutes 10 Minutes 3 Minutes 3 Minutes 5 Minutes
Cold Water Follow detergent manufacturer’s recommendation Follow detergent manufacturer’s recommendation Cold Water 180°F (82°C)
N/A Enzymatic or alkaline detergent Neutralizing agent (as needed) N/A N/A
Drying
No Drying phase
Caution: DO NOT use the drying phase with the automated washer-disinfector when cleaning the sterilizable battery. Use of the drying phase may shorten the life of the battery pack.
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DrillSaw Sports 400™ System User’s Guide 1. 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 reinspect. 2. For the sterilizable battery, dry the battery pack with a soft, low-linting cloth or medical grade compressed air at less than 20 psi pressure. 3. Proceed to Sterilization section.
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DrillSaw Sports 400™ System User’s Guide 6.0 Sterilization Sterilization is to be performed following cleaning, and sterile packaging prior to use. Single devices should be packed as to ensure that the pack is large enough to contain the device without stressing the seals. Devices may also be placed into appropriate Arthrex instrument cases as provided (not applicable to sterilizable battery). Packaging for single devices or sets should be completed utilizing a pouch or wrap which conforms to the recommended specifications for steam sterilization as outlined below. If a wrap is utilized, it should be completed following AAMI double-wrap or equivalent guidelines with an appropriate wrap (cleared by the FDA or the local governing body). Only Arthrex devices should be included in the cases. These validated instructions are not applicable to cases that include devices not intended to be used with Arthrex cases. After sterilization in the autoclave, let the accessory device cool down slowly. NEVER force the cooling of the handpiece or accessories. This will damage the electronic components and seals. 6.1 Approved Sterilization - Handpiece, Attachments, Aseptic Battery Housing and Aseptic Transfer Kit (Single Devices or Sets) Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed in the table below. Sterilizers vary in design and performance characteristics. Cycle parameters and the load configuration should always be verified against the sterilizer manufacturer’s instructions.
RECOMMENDED STEAM STERILIZATION PARAMETERS
Cycle Type Pre-Vacuum Gravity-Displacement
Minimum Exposure Temperature 132°C (270°F) 132°C (270°F)
Minimum Exposure Time 4 minutes 30 minutes
Minimum Drying Time 30 minutes 30 minutes
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DrillSaw Sports 400™ System User’s Guide * Caution: To maintain the highest possible level of performance and reliability on handpieces and attachments, the drying time should be run every sterilization cycle. Operating a handpiece or attachment that has not cooled and dried sufficiently may also decrease product reliability and/or performance.
Note: Immediate-use (flash) steam sterilization should only be used as an emergency procedure. Refer to AAMI ST79 for further instructions and limitations. 6.2 Approved Sterilization – Sterilizable Battery ONLY Visually inspect battery before sterilization. NEVER autoclave a damaged battery. Exceeding sterilization parameters, including dry time, may significantly shorten battery life. If a sterilizer requires a dry time setting, always use the minimum allowed programmable dry time setting for the sterilizer. Ensure battery has cooled down before use with handpieces or subsequent charging cycle. Sterilized batteries should be used within 48 hours of sterilization cycle for maximum usable battery life. Do not sterilize battery pack while attached to the handpiece! Sterilize battery with the parameters as follows:
RECOMMENDED STEAM STERILIZATION PARAMETERS
Cycle Type Pre-Vacuum
Minimum Exposure Temperature 132°C (270°F)
Minimum Exposure Time 3 minutes
Dry Time No Dry Time
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 (except for sterilizable battery). In the event a flash autoclave cycle is used to achieve sterility, the handpiece may not function until it has cooled to room temperature. Note that using force cooling the device may damage internal parts which are sealed. Force cooling with wet towels may cause condensation inside the device and can
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DrillSaw Sports 400™ System User’s Guide lead to corrosion which can lead to intermittent running and potentially no function at all. WARNING! 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. The agents for transmission of Creutzfeldt-Jakob disease are believed to be resistant to normal disinfection and sterilization processes. Therefore, the normal processing methods of decontamination and sterilization as described above may not be appropriate where CJD transmission is a risk. In general, the tissues that come into contact with orthopedic surgical instruments are those of low TSE infectivity. However, take particular precautions when handling instruments that have been used on known, suspected, or at-risk patients. Refer to AAMI ST79 for further information.
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DrillSaw Sports 400™ System User’s Guide 7.0 Maintenance While no maintenance is required, regular proper cleaning and handling of your DrillSaw Sports 400 System is the best way to protect your investment and avoid non-warranty repairs. Recommended care and handling of the DrillSaw Sports 400 System includes proper day-today 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. Your authorized Arthrex service department is extremely knowledgeable about the Arthrex DrillSaw Sports 400 System and will provide professional service. Any services and/or repairs carried out by any unauthorized repair facility may result in reduced performance of the instruments or instrument failure. Periodic Maintenance The product should be inspected prior to and after each use to ensure that the DrillSaw Sports 400 System and accessories are not damaged or worn. If it becomes necessary to return the DrillSaw Sports 400 System unit to Arthrex for service, please sterilize it before shipping.
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DrillSaw Sports 400™ System User’s Guide 8.0 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 [email protected] from 8:00 AM to 5:00 PM CET. Additional Technical Information Contact your Arthrex representative if you require more comprehensive technical information. Other information will be provided upon request by Arthrex Approved Service Personnel.
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DrillSaw Sports 400™ System User’s Guide 9.0 Repair Policy Contact Arthrex for a return authorization number and instructions, prior to returning the device.
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DrillSaw Sports 400™ System User’s Guide 10.0 End of Life, Environmental Directives WEEE Directive on Waste Electrical and Electronic Equipment The Directive on Waste Electrical and Electronic Equipment obliges manufacturers, importers, and/or distributors of electronic equipment to provide for recycling of the electronic equipment at the end of its useful life. Do not dispose of WEEE in unsorted municipal waste. The WEEE symbol on the product or its packaging indicates that this product must not be disposed of with other waste. Instead, it is your responsibility to dispose of your waste equipment by handing it over to a designated collection point for the recycling of Waste Electrical and Electronic Equipment. The separate collection and recycling of your waste equipment at the time of disposal will help conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment. 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. Specific guidelines for the disposal of Li-Ion batteries The rechargeable Arthrex DrillSaw Sports 400 battery pack contains Lithium-Ion. At the end of its useful life please follow the current local, state and national regulations regarding environmental and product safety considerations. - Do not disassemble Li-Ion battery packs. - Do not dispose in fire. - The disposal of Li-Ion batteries as municipal waste is prohibited. For more information in regard to the correct disposal of Li-Ion batteries, please contact Arthrex Customer Service department.
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DrillSaw Sports 400™ System User’s Guide
11.0 Electromagnetic Emissions
Table 21
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 RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3
Compliance Group 1 Class A
Electromagnetic environment – guidance The DrillSaw Sports 400 System uses RF energy only for its internal function. Therefore, its RF emissions are very low and not likely to cause any interference with nearby electronic equipment.
Class A Complies
The DrillSaw Sports 400 System is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
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DrillSaw Sports 400™ System User’s Guide
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.
Immunity test Electrostatic discharge (ESD) IEC 61000-4-2
IEC 60601 test level ± 8kV contact ± 15 kV air
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8
30 A/m
Compliance level ± 8 kV contact ± 15 kV air 30 A/m @ 50 & 60 Hz
Electromagnetic environment guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Table 23 Guidance and Manufacturer's Statement - Electromagnetic Immunity (cont’d)
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.
Immunity test Radiated RF IEC 61000-4-3
IEC 60601 test level 3 V/m 80 MHz to 2.7 [email protected] 1kHz AM modulation
Compliance level 3 V/m
Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the Model AR-400, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d 3.5 /V1 P = 1.2 P d 3.5/V1 P =1.2 P 80 MHz to 800 MHz d 7 / E1 P = 2.3 P 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a
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Immunity test
IEC 60601 test level
DrillSaw Sports 400™ System User’s Guide
Compliance level
Electromagnetic environment - guidance should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol:
Proximity Field from Wireless Transmitters IEC 61000-4-3
9 V/m to 28 V/m
9 V/m to 28 V/m
Frequency bands from IEC 60601-1-2 Table 9
Frequency bands from IEC 606011-2 Table 9
For some services, only the uplink frequencies are included. Carrier shall be modulated using a 50% Duty cycle square wave signal As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it is worst case
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Model AR-400 is used exceeds the applicable RF compliance level above, the Model AR-400 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-400 b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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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 – 7.4 mm Jacobs Chuck Attachment, Keyless
AR-400DJH50
0 – 5.0 mm Hybrid Jacobs Chuck Drill Attachment
AR-400DJH74
0 – 7.4 mm Hybrid Jacobs Chuck Drill Attachment
AR-400DT
Trinkle Drill Attachment
AR-400DHA
Harris Drill Attachment
AR-400ARL
Radiolucent Drive Adapter Right Angle Drive
AR-400RZH
Zimmer Hudson Reamer Attachment
AR-400RAOP
Large AO Reamer Attachment
AR-400RHU
Hudson Reamer Attachment
AR-400RJ74
0 – 7.4 mm Jacobs Chuck Drill Attachment, Keyed
AR-400RJH74
0 – 7.4 mm Hybrid Jacobs Chuck Reamer Attachment
AR-400DHS
Dynamic Hip Screw Drill Attachment
AR-400SAG
Sagittal Saw Attachment for 300 Series Saw Blades
AR-400PD
0 – 3.2 mm Wire and Pin Driver Attachment
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