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Table of contents

DFU-0253-4r0_fmt_en-US

Page i

General Warnings and Safety Notices - Read This First .................... 1

Important Safety Conventions ............................................................................ 1

Symbol Definitions ............................................................................................. 4

Shipping, Unpacking, and Warranty Information ................................................ 6

Product Description and Intended Use .............................................. 7

Product Description ............................................................................................ 7

Intended Use ...................................................................................................... 7

Contraindications ............................................................................................... 7

Set Composition ................................................................................................. 7

Product Functions .............................................................................................. 9

AR-400 Handpiece ............................................................................................... 9

AR-400UB Aseptic Battery Pack ..........................................................................10

AR-400UBH-1 Aseptic Battery Housing ...............................................................11

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

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

Cleaning and Disinfecting ................................................................ 29

Содержание DrillSaw Sports 400

Страница 1: ...ting personnel must read this User s Guide thoroughly prior to using this system and follow all safety warnings cautions and precautions Arthrex Inc 1370 Creekside Blvd Naples FL 34108 1945 USA Toll Free 1 800 934 4404 www arthrex com Arthrex GmbH Erwin Hielscher Strasse 9 81249 München Germany Tel 49 89 909005 0 Fax 49 89 909005 280 www arthrex de DFU 0253 4 Revision 0 06 2020 2020 Arthrex Inc Al...

Страница 2: ...anty 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 ...

Страница 3: ...EMC and Regulatory Requirements 15 3 4 Electromagnetic Compatibility EMC 16 3 5 Risks due to electromagnetic fields 16 4 4 0 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...

Страница 4: ...6 0 0 Sterilization 34 6 1 Approved Sterilization Handpiece Attachments Aseptic Battery Housing and Aseptic Transfer Kit 34 6 2 Approved Sterilization Sterilizable Battery 35 Transmissible Spongiform Encephalopathy Agents 36 7 7 0 0 Maintenance 37 Periodic Maintenance 37 8 8 0 0 Technical Support 38 Additional Technical Information 38 9 9 0 0 Repair Policy 39 1 10 0 0 0 End of Life Environmental D...

Страница 5: ...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 Ase...

Страница 6: ...le 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 ...

Страница 7: ...eries 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...

Страница 8: ...ises 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 saf...

Страница 9: ...he instructions issued by the manufacturer of the cleaning 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 ...

Страница 10: ...s side up Keep dry Temperature limits for storage and transport 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 Atmospheric pressure limitation for storage and transport Authorized representative in the European Community Humidity limits for storage and transport Serial ...

Страница 11: ...ctive 93 42 EEC Quantity Do not use if package is damaged Type B Device Not suitable for intracardiac applications RF symbol Non ionizing 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 ...

Страница 12: ...t 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 ...

Страница 13: ...al 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 Not for use on spinal or neuro procedures Only use Arthrex acc...

Страница 14: ... 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 ...

Страница 15: ... 5 1 1 AR 400 Handpiece The handpiece functions are identified and defined below Figure 1 Handpiece Table 1 Handpiece 1 Collet Release button 2 Mode switch 3 Battery connection 4 Safe position 5 Forward only Reverse is locked out 6 All functions 6a Forward 6b Reverse 6c Oscillate 1 2 3 4 5 6 6a 6b 6c ...

Страница 16: ...en US Page 10 of 46 2 2 5 5 2 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 Table 2 AR 400UB Aseptic Battery Pack 1 Battery contacts 2 Handle 1 2 ...

Страница 17: ... Housing are identified and defined below Figure 3 Aseptic Battery Housing Table 3 Aseptic Battery Housing 1 Battery contacts 2 Battery housing door 3 Release tab to remove battery housing from handpiece 4 Lever to open and close battery housing door 5 5a Lever position when battery housing door closed 5b Lever position when battery housing door open 1 2 3 4 5b 5a ...

Страница 18: ... 46 2 5 4 AR 400SB Sterilizable Battery The main elements of the AR 400SB Sterilizable Battery are identified and defined below Figure 4 AR 400SB Sterilizable Battery Table 4 AR 400SB Sterilizable Battery 1 Battery contacts 2 Release tab to remove battery from handpiece 1 2 ...

Страница 19: ...rillSaw 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 Operati...

Страница 20: ...ser s Guide DFU 0253 4r0_fmt_en US Page 14 of 46 Attachments Table 8 Attachments Drill Speed 1 330 rpm Drill Torque 3 2 Nm 28 inch pounds Reamer Speed 330 rpm Reamer Torque 9 Nm 79 inch pounds Cutting 23 000 cpm Sterilization YES ...

Страница 21: ...th Canada Class Class II Safety Certifications Domestic Certification ANSI AAMI ES60601 1 2005 C2 A2 Canadian Certification CSA C22 2 No 60601 1 2008 EU Certification EN IEC 60601 1 3rd ed Amendment 1 EMC Certifications EMC Certification EN 60601 1 2 4th Safety Certification Marking UL CE Classification MDD 93 42 EEC Annex IX Rule 9 Class IIa For all other accessories refer to accompanying DFUs fo...

Страница 22: ...ices 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 electrom...

Страница 23: ...piece These instructions describe the procedure for connecting and removing an attachment to the AR 400 handpiece Figure 5 Connecting and removing an attachment Table 10 Connecting and removing an attachment 1 Insert the attachment until it snaps into place 2 To remove the attachment Press the collet release button and hold Pull the attachment away from the handpiece W A R N I N G Always ensure th...

Страница 24: ...or connecting a battery to the AR 400 handpiece Figure 6 Connecting a battery Table 11 Connecting a battery 1 Align the rails on top of the battery with the bottom of the handpiece 2 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 3 The battery is fully connected 1 2 3 ...

Страница 25: ...ving a battery from the Handpiece These instructions describe the procedure for removing a battery from the AR 400 handpiece Figure 7 Removing a battery Table 12 Removing a battery 1 Press down on the battery release tab and hold 2 Move the handpiece away from the battery along the rails 2 1 ...

Страница 26: ...s describe the procedure for inserting a drill bit into the AR 400 quick connect attachments Figure 8 Insert a drill bit Table 13 Insert a drill bit 1 Pull back on the quick connect collar and hold it in place 2 Insert the drill bit into the end of the attachment 3 Release the collar and check to make sure the drill bit is secured in the attachment 1 3 2 ...

Страница 27: ...dure for inserting a drill bit to the AR 400 keyed chucks Figure 9 Insert a drill bit into a Jacobs Chuck Table 14 Insert a drill bit into a Jacobs Chuck 1 Open the collar of the Jacobs Chuck enough for the drill bit to fit into the attachment 2 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 1 2 ...

Страница 28: ...drill bit to the AR 400 keyless attachments Figure 10 Insert a drill bit into a Keyless Chuck Table 15 Insert a drill bit into a Keyless Chuck 1 Open the collar of the Chuck enough for the drill bit to fit into the attachment 2 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 1 2 ...

Страница 29: ...re for inserting a sawblade into the AR 400 sagittal saw attachment Figure 11 Insert a sawblade Table 16 Insert a sawblade 1 Press the button on top of the attachment to open the collet 2 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 1 2 ...

Страница 30: ...w head Table 17 Indexing the saw head 1 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 2 Tu...

Страница 31: ...00JLD j latch attachments Figure 13 Inserting a rotary instrument burr drill bit Table 18 Inserting a rotary instrument burr drill bit 1 Twist the attachment collet lock to the unlocked open position 2 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 ...

Страница 32: ...4 Inserting a wire pin Table 19 Inserting a wire pin 1 Press the wire pin into the retaining mechanism at the opening of the attachment 2 Slide the wire pin into the driver until the desired length is reached 3 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...

Страница 33: ... Transfer A 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 seat...

Страница 34: ...DrillSaw Sports 400 System User s Guide DFU 0253 4r0_fmt_en US Page 28 of 46 3a The assembled battery is now ready to be placed on the handpiece ...

Страница 35: ...sing 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 instruct...

Страница 36: ...aning 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 spec...

Страница 37: ...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 fl...

Страница 38: ...d 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 RECOMMENDED WASHING CYCLE PARAMETERS Phase Recirculation Time Temperature ...

Страница 39: ...53 4r0_fmt_en US Page 33 of 46 5 Remove the devices from the washer disinfector following the completion of the program and check devices for visible soil Repeat cleaning if soil is visible and re inspect otherwise proceed to Sterilization section ...

Страница 40: ... 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 Handpiece Attachments Aseptic Batt...

Страница 41: ... cycle Sterile batteries should be used within 48 hours of sterilization cycle for maximum usable battery life Sterilize battery with the parameters as follows RECOMMENDED STEAM STERILIZATION PARAMETERS Sterilization Type Minimum Temperature Minimum Exposure Time Dry Cycle Steam Pre Vacuum 132 C 270 F 3 minutes None Do not sterilize battery pack while attached to handpiece After Sterilization The ...

Страница 42: ...gents 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 i...

Страница 43: ...s 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 Maintena...

Страница 44: ...or contact the Arthrex Technical Support Hotline at 1 888 420 9393 Monday through Friday from 9 00 AM to 5 00 PM EST or at 49 89 90 90 05 8800 or techsupport arthrex de from 8 00 AM to 5 00 PM CET 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 Pe...

Страница 45: ...DrillSaw Sports 400 System User s Guide DFU 0253 4r0_fmt_en US Page 39 of 46 9 9 0 0 Repair Policy Contact Arthrex for a return authorization number and instructions prior to returning the device ...

Страница 46: ...c 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 Departm...

Страница 47: ...ompliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 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 RF emissions CISPR 11 Class A The DrillSaw Sports 400 System is suitable for use in all establishments other than domestic and those...

Страница 48: ...ment 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 IEC 60601 test level Compliance level Electromagnetic environment guidance Radiated RF I...

Страница 49: ...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 ...

Страница 50: ...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 ...

Страница 51: ... 400UB Aseptic Battery Pack for AR 400UBH 1 AR 400UBH 1 Aseptic Battery Housing for AR 400UB AR 400ATK 1 Aseptic Transfer Kit for AR 400UB Sterilizable Battery AR 400SB Sterilizable Battery Charger and Charging Bays AR 400UBC Universal Battery Charger AR 400UBC 4 Charging Bay for AR 400UBC Aseptic Battery Pack AR 400UBC S4 Charging Bay for AR 400UBC Sterilizable Battery ...

Страница 52: ...370 Creekside Blvd Naples FL 34108 1945 USA www arthrex com Customer Service 1 800 934 4404 Toll Free Technical Support 1 888 420 9393 Monday through Friday 9 00 AM 5 00 PM EST Arthrex GmbH Erwin Hielscher Strasse 9 81249 München Germany Tel 49 89 909005 0 www arthrex de All rights reserved ...

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