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AR-300
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. 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-0223-3 Revision 0 06/2020 © 2020 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 1.1 Important Safety Conventions ............................................................................ 1 1.2 Symbol Definitions ............................................................................................. 5 1.3 Shipping, Unpacking, and Warranty Information ................................................ 6 2.0 Product Description and Intended Use .............................................. 7 2.1 Product Description ............................................................................................ 7 2.2 Intended Use...................................................................................................... 7 2.3 Contraindications ............................................................................................... 7 2.4 Set Composition................................................................................................. 8 2.5 Product Functions .............................................................................................. 9 2.5.1 AR-300 Handpiece ............................................................................................... 9 2.5.2 AR-300L Battery Pack, Li-Ion...............................................................................10 2.5.3 AR-3000LBH Battery Housing .............................................................................11 3.0 Technical Specifications .................................................................. 12 3.1 Handpiece ........................................................................................................ 12 3.2 Attachments ..................................................................................................... 13 3.3 Safety, EMC, and Regulatory Requirements ................................................... 14 3.4 Electromagnetic Compatibility (EMC)............................................................... 14 3.5 Risks due to electromagnetic fields:................................................................. 15 4.0 Setup ............................................................................................... 16 4.1 How to Set Up the Handpiece .......................................................................... 16 4.2 Setup - Connecting and removing an attachment to the handpiece................. 16 4.3 Setup - Connecting a battery housing to the handpiece................................... 17 4.4 Setup - Removing the battery housing from the handpiece ............................. 18 4.5 Setup - Quick Connect of Drilling and Reaming Attachments .......................... 19 4.6 Setup - Drilling and Reaming Attachments, Keyed Jacobs Chuck ................... 20 4.7 Setup - Drilling and Reaming Attachments, Keyless Chuck ............................. 21 4.8 Setup - Saw Attachment .................................................................................. 22 4.9 Setup – Burr / Drill Attachments ....................................................................... 23 4.10 Setup - Wire/Pin Driver Attachment ................................................................. 24 4.11 Battery Housing/Battery Pack/Transfer Plate ................................................... 25 5.0 Cleaning and Disinfecting ................................................................ 26
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Table of contents 5.1 Battery Pack..................................................................................................... 26 5.2 Detergent Selection.......................................................................................... 27 5.3 Preliminary Cleaning ........................................................................................ 27 5.3.1 Handpieces and Battery Housings .......................................................................28 5.3.2 Attachments and Transfer Plates .........................................................................28 5.4 Automated Cleaning and Thermal Disinfection ................................................ 28 6.0 Sterilization ...................................................................................... 30 6.1 Approved Sterilization ...................................................................................... 30 6.2 Transmissible Spongiform Encephalopathy Agents ......................................... 32 7.0 Maintenance .................................................................................... 33 7.1 Periodic Maintenance....................................................................................... 33 8.0 Technical Support............................................................................34 8.1 Additional Technical Information ...................................................................... 34 9.0 Repair Policy ................................................................................... 35 10.0 End of Life, Environmental Directives .............................................. 36 10.1 Specific guidelines for the disposal of Li-Ion batteries...................................... 36 11.0 Electromagnetic Emissions..............................................................37
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Table of contents List of Figures Figure 1 Handpiece ............................................................................................................................... 9 Figure 2 Battery Pack .......................................................................................................................... 10 Figure 3 Battery Housing.................................................................................................................... 11 Figure 4 Connecting and removing an attachment ........................................................................ 16 Figure 5 Connecting a battery housing ............................................................................................ 17 Figure 6 Removing the battery housing ........................................................................................... 18 Figure 7 Insert a drill bit ..................................................................................................................... 19 Figure 8 Insert a drill bit into a Jacobs Chuck.................................................................................. 20 Figure 9 Insert a drill bit into a Keyless Chuck ............................................................................... 21 Figure 10 Insert a sawblade.................................................................................................................. 22 Figure 11 Insert a drill / burr bit .......................................................................................................... 23 Figure 12 Insert a pin / wire ................................................................................................................. 24 Figure 13 Insert drop-in battery to the Battery Housing ................................................................. 25
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Table of contents List of Tables Table 1 Handpiece ............................................................................................................................... 9 Table 2 Battery Pack .......................................................................................................................... 10 Table 3 Battery Housing.................................................................................................................... 11 Table 4 Handpiece AR-300 ............................................................................................................... 12 Table 5 Ambient conditions for operation ..................................................................................... 12 Table 6 Ambient conditions for storage (in shipping packaging)............................................... 13 Table 7 Attachments .......................................................................................................................... 13 Table 8 Safety, EMC, and Regulatory Requirements.................................................................... 14 Table 9 Connecting and removing an attachment ........................................................................ 16 Table 10 Connecting a battery housing ............................................................................................ 17 Table 11 Removing the battery housing ........................................................................................... 18 Table 12 Insert a drill bit ..................................................................................................................... 19 Table 13 Insert a drill bit into a Jacobs Chuck.................................................................................. 20 Table 14 Insert a drill bit into a Keyless Chuck ............................................................................... 21 Table 15 Insert a sawblade.................................................................................................................. 22 Table 16 Insert a burr / drill bit .......................................................................................................... 23 Table 17 Insert a pin / wire ................................................................................................................. 24 Table 18 Drop-in battery ..................................................................................................................... 25 Table 19 Guidance and Manufacturer's Declaration - Electromagnetic Emissions.................... 37 Table 20 Guidance and Manufacturer's Statement - Electromagnetic Immunity....................... 38 Table 21 Guidance and Manufacturer's Statement - Electromagnetic Immunity (cont’d) ........ 39 Table 22 Accessories for DrillSaw Mini 300 System™ ................................................................... 40
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DrillSaw Mini 300™ 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 Mini 300 System User’s Guide identifies critical, important, and useful information using these symbols and conventions. 1.1 Important Safety Conventions Users of this device are encouraged to contact their Arthrex representative if they require a more comprehensive surgical technique. 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 Mini 300 System for the first time, store it at room temperature for 24 hours. 3. Charge batteries before every use. Follow instructions for charging 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. 7. Never touch the chuck mechanism of the handpiece while the motor is still in motion. 8. Avoid overheating at the treatment site by following the duty cycle and using sharp cutting and drilling accessories. 9. No modification of the AR-300 or the accessories is allowed. 10. 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.
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DrillSaw Mini 300™ System User’s Guide 11. Misuse, unauthorized assembly and modifications or repairs to the AR-300 system, or non-compliance with these instructions relieves Arthrex of all liability for claims under warranty or other claims. 12. 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. 13. 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. 14. After autoclaving, the accessory devices are VERY HOT. Handle with care to avoid burns. 15. The equipment is NOT suitable for use in potentially explosive atmospheres or with potentially explosive mixtures of anesthetic substances containing oxygen or nitrous oxide. 16. 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. 17. 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. 18. 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. 19. Do not interfere with the rotary instruments or saws while they are in motion. 20. Never touch an attachment or press the release mechanism of the collet while the device is in motion. 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. 24. Disconnect the rechargeable battery immediately after using the handpiece. 25. Only use accessories which are in proper working order. Damaged or improperly functioning accessories must be sent in for service. 26. It is recommended to have a backup system available should the need arise.
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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 battery packs are NOT to be cleaned and disinfected in a thermo 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 housing, ensure the receptacles are clean and dry. 10. Always comply with the instructions issued by the manufacturer of the cleaning disinfectant regarding concentration, exposure times, temperature, and material compatibility. 11. Remove all accessories, including attachments, battery pack, and accessories 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.
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DrillSaw Mini 300™ System User’s Guide 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. • 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.
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1.2 Symbol Definitions Safety Sign Follow operating instructions Non sterile Caution Keep dry Electrical Hazard, dangerous voltages are present. Never attempt to repair the equipment. Only trainer service personnel may remove the cover, or obtain access to system components Type B Device – Not suitable for intracardiac applications Authorized representative in the European Community Serial number DFU-0223-3r0_fmt_en-US
DrillSaw Mini 300™ System User’s Guide Caution: Federal law restricts this device to sale by or on the order of a physician. Fragile, handle with care This side up Temperature limits for storage and transport Atmospheric pressure limitation for storage and transport Humidity limits for storage and transport Manufacturer Date of manufacture; year and month. Page 5 of 42
Electrical waste Catalog number Quantity
DrillSaw Mini 300™ System User’s Guide The product meets the essential requirements of Medical Device Directive 93/42/EEC Do not use if package is damaged RF symbol. Nonionizing electromagnetic radiation
• 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.
1.3 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 Mini 300™ System User’s Guide 2.0 Product Description and Intended Use 2.1 Product Description The Arthrex DrillSaw Mini 300 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. The handpiece utilizes a drop-in style battery that does not go through the sterilization process, which provides longer life from the battery pack. The battery pack is used in conjunction with a sterile battery case that holds the battery and prevents contact with the sterile surgical field. 2.2 Intended Use The DrillSaw Mini 300™ System is a modular electric system, consisting of a handpiece drive, various accessories, and a charging station for machining bones. It can be used for small bone orthopedic and sports medicine applications to make osteotomies, drill holes, and drive pins and wires. 2.3 Contraindications The DrillSaw Mini 300 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 • Not for use on spinal or neuro procedures Only use Arthrex accessories. WARNING! Misuse may damage the DrillSaw Mini 300 System and cause risks and hazards for patients, users and third parties.
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DrillSaw Mini 300™ System User’s Guide 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. 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) • Battery Charger (see DFU-0256-XX) • Instrument Tray(s) • Elongation handle (optional device)
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2.5 Product Functions
2.5.1 AR-300 Handpiece The handpiece functions are identified and defined below.
Figure 1
Handpiece
3
1
5
6
7 2 4
Table 1 1. 2. 3. 4. 5. 6. 7.
Handpiece Chuck mechanism Speed regulator Battery housing R/S/F Switch Forward drive (F) Safe position (S) Reverse drive (R)
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2.5.2 AR-300L Battery Pack, Li-Ion The main elements of the AR-300L battery pack are identified and defined below.
Figure 2
Battery Pack
2
1
Table 2 1. 2.
Battery Pack Battery contacts Handle
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2.5.3 AR-3000LBH Battery Housing The main elements of the Battery Housing are identified and defined below.
Figure 3
Battery Housing
3
2
1
Table 3 1. 2. 3.
Battery Housing Battery contacts Battery housing door Release tab to remove battery housing from handpiece
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DrillSaw Mini 300™ System User’s Guide
3.0 Technical Specifications
3.1 Handpiece
Table 4 Width
Handpiece AR-300 94 mm (3.7”)
Height
47 mm (1.85”)
Depth
175 mm (6.889”)
Weight
550 g (1.21 lbs.)
Cannulation
2.4 mm (0.0945”)
Protection
IPX0
Speed
See Section 3.2 Table 7 Attachments
Torque
See Section 3.2 Table 7 Attachments
Applied part type
B
Pollution level
2
Overvoltage category II
Altitude
Up to 3,000 m [9,842 ft.] above sea level
Duty Cycle*
Operating Type S3 per IEC 60034-1
At 25°C (77°F) Ambient Temperature:
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° 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 5
Ambient conditions for operation
Temperature
10° to 40 °C (50° to 104 °F)
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Relative Humidity
DrillSaw Mini 300™ System User’s Guide 15% to 80% (relative), non-condensing
Table 6
Ambient conditions for storage (in shipping packaging)
Temperature
-40° to +70°C (-40° to +158°F)
Relative Humidity
8% to 80% (relative), non-condensing
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
YES
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3.3 Safety, EMC, and Regulatory Requirements
Table 8
Safety, EMC, and Regulatory Requirements
Parameter System Classification
Parameter Value IEC 60601-1
FDA class
EU class
Health Canada Class
Safety Certifications
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 CSA C22.2 No 60601.1 ( EN/IEC 60601-1 EN/IEC 60601-1-2
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. 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.
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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: 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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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 an attachment to the AR300 handpiece.
Figure 4
Connecting and removing an attachment
1
2
Table 9 1. 2.
Connecting and removing an attachment To Insert the attachment - Turn the handpiece drive chuck mechanism - Push the adaptor into the locking mechanism and release the chuck mechanism To remove the attachment: - Turn the handpiece drive chuck mechanism
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- Pull the attachment away from the handpiece
WARNING! 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.
Figure 5
Connecting a battery housing
1
Table 10 1. 2. 3.
Connecting a battery housing Pressing the locking dive and push the battery housing into the handpiece drive as far as it will go. You will hear an audible click once the retaining tab mechanism is engaged to the handpiece. Battery is fully connected.
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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
1
2
Table 11 1. 2.
Removing the battery housing Pressing the locking device and hold. Move the battery housing away from the handpiece.
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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.
Figure 7
Insert a drill bit
1
3
2
Tabl1e 12 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-300 keyed chucks.
Figure 8
Insert a drill bit into a Jacobs Chuck
1
2
Table 13 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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4.7 Setup - Drilling and Reaming Attachments, Keyless Chuck These instructions describe the procedure for inserting a drill bit to the AR-300 keyless attachments.
Figure 9
Insert a drill bit into a Keyless Chuck
1
2
Table 14 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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4.8 Setup - Saw Attachment These instructions describe the procedure for inserting a sawblade to the AR-300 sagittal saw attachments and reciprocating saw attachment.
Figure 10
Insert a sawblade
1
2
Table 15 1. 2.
Insert a sawblade Operate the twist chuck or the push-button and push the saw in as far as it will go. Release the twist chuck or the push-button - Pull on the blade to ensure it is fully seated in the attachment
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4.9 Setup – Burr / Drill Attachments These instructions describe the procedure for connecting the burr to the burr / drill attachment.
Figure 11
Insert a drill / burr bit
1
2
3
Table 16 1. 2. 3.
Insert a burr / drill bit Operate the twist chuck Push the rotary instrument in and turn it until you hear it engage. Release the twist chuck and check that the connection is secure by pulling in an axial direction.
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4.10 Setup - Wire/Pin Driver Attachment These instructions describe the procedure for inserting a pin to the AR-300 pin driver attachment.
Figure 12
Insert a pin / wire
2
1
3
Table 17 1. 2. 3.
Insert a pin / wire Pull the lever of the pin or wire driver back and insert the pin or wire. Slide the pin or wire into the driver until the desired length is reached. Do not insert the wire up to the limit stop in the handpiece drive. Release the lever in order to fix the pin or wire in place.
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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.
Figure 13
Insert drop-in battery to the Battery Housing
1
2
3
A
B
B
A
A
A
3a
Table 18 A B 1. 2. 3.
Drop-in battery Sterile Technician Non-sterile Circulating Nurse The Sterile Technician holds sterile battery housing upright and places the sterile transfer plate on top. The Non-sterile Circulating Nurse places the unsterile battery down into the housing through the sterile transfer plate until it is fully seated. The Non-sterile Circulating Nurse then removes the sterile transfer plate, 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 Mini 300™ System User’s Guide 5.0 Cleaning and Disinfecting The handpiece and attachments are supplied non-sterile and must be adequately cleaned, disinfected, and sterilized prior to use or re-use. Follow your country-specific directives, standards and guidelines for cleaning, disinfection and sterilization. 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.
With the exception of the battery pack and charging unit, Arthrex recommends processing system components (handpieces, attachments, transfer plates and battery housings) with an automated procedure using a washer/disinfector. Remove any attachments and the battery housing from the handpiece prior to cleaning. Remove the battery pack from the battery housing and clean and disinfect the battery pack according to the instructions of Section 5.1. Do NOT autoclave the battery pack, or put it through the Washer/Disinfector.
5.1 Battery Pack Do NOT autoclave the battery pack. It must be cleaned and disinfected after use. Do not immerse the battery pack or place them 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. Batteries should be disinfected when they are not on the charging station. Avoid any pooling of cleaning 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 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.
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DrillSaw Mini 300™ System User’s Guide 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 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 cleaning chemistries are utilized, care should be taken to ensure appropriate rinsing, as validated by the end-user facility, and neutralization steps are taken so as to 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 handpieces, attachments, transfer plates, and battery housings prior to automated cleaning and thermal disinfection is important to ensure that cannulations and other difficult-to-access areas are clean.
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DrillSaw Mini 300™ System User’s Guide 5.3.1 Handpieces and Battery Housings 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 Transfer Plates 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 them to soak and sonicate for a minimum of 10 minutes. 6. Remove the devices from the solution and proceed to Section 5.4. 5.4 Automated Cleaning and Thermal Disinfection 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 battery housing are open and point downward so that they do not retain water. 2. If using alkaline cleaning agents, a neutralization step should be utilized as appropriate. 3. 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 Mini 300 System handpieces. Ultrasonic cleaning of the handpiece is NOT approved and can cause damage to the handpiece.
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DrillSaw Mini 300™ System User’s Guide
Phase
RECOMMENDED WASHING CYCLE PARAMETERS
Recirculation Time
Temperature
Detergent
Pre-Wash
3 Minutes
Cleaning Wash
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
4. 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.
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DrillSaw Mini 300™ System User’s Guide
6.0 Sterilization Sterilization is to be performed following cleaning, disinfection, and sterile packaging prior to use. 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. Place all the components in the instrument tray. While you may use filtered trays, it is recommended that you use one of the Arthrex approved instrument trays. If you are using a filtered tray, please observe the manufacturer’s recommendations for that filtered tray. Packaging 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 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. 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
* 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.
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DrillSaw Mini 300™ System User’s Guide Note: Immediate-use (flash) steam sterilization should only be used as an emergency procedure. Refer to AAMI ST79 for further instructions and limitations.
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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 to ensure all electrical contacts are dry as to prevent malfunctions. In the event a flash (IUSS) cycle is used to achieve sterility, the handpiece may not function until it has cooled to room temperature. Note that using forced cooling of the device may damage internal parts which are sealed. Forced cooling with wet towels may cause condensation inside the device and can 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. 6.2 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 Mini 300™ System User’s Guide 7.0 Maintenance While no maintenance is required, regular proper cleaning and handling of your DrillSaw Mini 300 System is the best way to protect your investment and avoid non-warranty repairs. Recommended care and handling of the DrillSaw Mini 300 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 Mini 300 System before each use. Your authorized Arthrex service department is extremely knowledgeable about the Arthrex DrillSaw Mini 300 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. 7.1 Periodic Maintenance The product should be inspected prior to and after each use to ensure that the DrillSaw Mini 300 System and accessories are not damaged or worn. If it becomes necessary to return the DrillSaw Mini 300 System unit to Arthrex for service, please sterilize before shipping.
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DrillSaw Mini 300™ 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. 8.1 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 Mini 300™ 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 Mini 300™ 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. 10.1 Specific guidelines for the disposal of Li-Ion batteries The rechargeable Arthrex DrillSaw Mini 300 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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11.0 Electromagnetic Emissions
Table 19
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 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 Mini 300 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 Mini 300 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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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.
Immunity test Electrostatic discharge (ESD) IEC 61000-4-2
IEC 60601 test level ± 8 kV 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.
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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.
Immunity test Radiated RF IEC 61000-4-3
IEC 60601 test level 3 V/m 80 MHz to 2.7 GHz @ 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-300, 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 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:
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-300 is used exceeds the applicable RF compliance level above, the Model AR-300 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-300 b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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Table 22 Accessories for DrillSaw Mini 300 System™
AR-300 AR-300B AR-300B-2 AR-300DAO-2 AR-300DJ AR-300DK30 AR-300DK45 AR-300DJH AR-300RAO AR-300RJ AR-300SAG AR-300SR AR-300WD16 AR-300PD24 AR-300L AR-300LBH AR-300ATK AR-300CA AR-300H AR-300C-G
Handpiece Burr Attachment 2.35mm Drill Attachment 2.35mm Drill Attachment – Style AO Drill Jacobs Chuck 0 – 0.4 mm Drill Keyless Chuck 0 – 3.0 mm Drill Keyless Chuck 2.0 – 4.5 mm Drill Jacobs Chuck Hybrid 0 – 5.0 mm Reamer Attachment - Style AO Reamer Jacobs Chuck 0 – 4.0 mm Saw Attachment - Sagittal Saw Attachment – Reciprocating Wire Driver Attachment 0.6 – 1.6 mm Pin Driver Attachment 1.6 – 2.4 mm Battery Pack, Li- Ion Battery Housing Transfer Kit Offset Adapter Elongation Handle Tray for AR-300
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AR-300C AR-300KEY AR-300HKEY AR-400UBC AR-400UBC-3
Instrument Case Replacement Key for Jacobs Chuck for AR-300 Replacement Key for Hybrid Chuck for AR-300 Universal Battery Charger Charging Bay for AR-300L and AR-600L, Aseptic Battery
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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. DFU-0223-3r0_fmt_en-US
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