Arthrex AR-8300
Contents
1. d 1 17P12 80 MHz to 800 MHz d 2 33P12 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 Interference may occur in the vicinity of equipment marked with the following symbol Gi 27 ArthraxSo Adapteur Power System User s Guide 13 0 Contact Information wd Arthrex Inc Naples Florida 34108 1945 USA Tel 1 239 643 5553 Fax 1 239 598 5534 Toll Free Technical Support 1 888 420 9393 Monday through Friday 9 00 AM 5 00 PM ET Website www arthrex com EC REP Arthrex Med Inst GmbH 85757 Karlsfeld Germany Tel 49 81 31 59 57 0 Fax 49 81 31 59 57 63 1 Website www arthrex de 13 1 Compliance Information The Adapteur Power System II AR 8300S is designed and tested in accordance with EN 60601 1 According to EN 60601 the console is Type BF Class 1 IPX1 rating Accessories are Type BF Class 1 IPX 8 According to MDD93 42 EEC Annex IX Rule 9 this device is classified as a Class Ila device 282. 2 brief tones that indicates the LOCKED state has been entered and Lock is displayed If the pedal was not held steady within the 15 second LOCK IN period then the Cruise function becomes DISARMED signified by a single audible 1 second alarm beep 3 REMOVE FOOT The operator is allowed to move the same pedal for the next 3 seconds without leaving the LOCKED state This is necessary since the act of taking the foot off of the pedal moves the pedal position Once the pedal is fully released or 3 seconds has elapsed whichever comes first then the system again responds to this pedal and disables the Cruise function At any time during or after this 3 second period i e during the Cruise Lock state if any OTHER pedal footswitch or panel switch is activated for that channel the Cruise function becomes DISARMED 4 DISABLE CRUISE LOCK If any other footswitch or front console panel button is activated while in the LOCKED state the Cruise function becomes DISARMED with the exception noted in item 3 Remove Foot 5 DISABLE CRUISE SET If the Toggle Cruise Control or Front Panel buttons are actuated at any time after the Cruise Control button is selected i e in the ARMED or LOCKED condition then the Cruise function becomes DISARMED 4 4 4 Toggle Function The toggle function is a button on footswitches that allows the operator to control the other handpiece without having to physically move the footswitch connecti
3. in the electromagnetic environment specified below The customer or the user of the AR 8300S Shaver System should assure that it is used in such an environment Immunity test TEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative TEC 61000 4 4 1 kV for input output lines 1 kV for input output lines 8 kV air 8 kV air humidity should be at least 30 TEC 61000 4 2 Electrical fast 2 kV for power 2 kV for power Mains power quality should be that of a typical transient burst supply lines supply lines commercial or hospital environment Surge TEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply lt 5 Ur 295 dip in UT for 0 5 cycle 40 Ur 95 Reduction 10ms 60 Reduction 100ms Mains power quality should be that of a typical commercial or hospital environment If the AR 8300S Shaver System requires continued operation during power mains interruptions it is recommended that the AR 8300S Shaver System be powered from an Abtei Adapteur Power Syste
4. 1 Console TABLE 7 AR 8300 CONSOLE SPECIFICATIONS Width 36 8 cm 14 5 inches Height 13 2 cm 5 2 inches Depth 32 5 cm 12 8 inches Weight 7 2 kg 16 lbs Water protection IPX1 Mains cable 10 A 250 V Power entry IEC 320 C13 module Fuse value AC input Cleaning disinfection and sterilization 6 3 Amp 250 VAC 2 0 cm 0 75 inches 87 264 VAC 47 63 Hz Refer to Sections 5 0 and 6 0 11 ArthraxSo Adapteur Power System User s Guide 2 3 2 Standard Footswitch TABLE 8 STANDARD FOOTSWITCH SPECIFICATIONS Functions Reverse Forward Oscillate Speed Increase and Toggle Width 23 6 cm 9 3 inches Height 2 5 cm 1 0 inches Depth 20 8 cm 8 2 inches Weight 2 2 kg 5 lbs Water protection IPX8 Cleaning disinfection Refer to Sections 5 0 and 6 0 and sterilization 2 3 3 Ambient Conditions for Operation TABLE 9 AR 8300S AMBIENT CONDITIONS FOR OPERATION 10 to 40 C 50 to 104 F 30 to 75 700 hPa to 1060 hPa 21 in Hg to 31 3 in Hg Temperature Relative humidity Air pressure 2 3 4 Ambient Conditions for Storage in shipping packaging TABLE 10 AR 8300S AMBIENT CONDITIONS FOR STORAGE Temperature Relative humidity Air pressure 40 to 70 C 40 to 158 F 0 to 100 non condensing 500 hPa to 1160 hPa 15 in Hg to 31 3 in Hg 3 0 Setup 3 1 How to Set Up the Console Users of this device are encouraged to contact their Arthrex r
5. Arthr amp o AR 8300S Adapteur Power System II User s Guide The Arthrex Adapteur Power System II User s Guide provides important information for the safe operation of all components of the Arthrex Adapteur Power System II Model AR 8300 including accessories Read this User s Guide thoroughly prior to using this system and keep it in an easily accessible place for use by all operating personnel Read and follow all safety warnings cautions and notes U S PATENT PENDING C 0086 wi Arthrex Inc Naples FL 34108 1945 USA Toll Free 800 934 4404 www arthrex com Arthrex Med Inst GmbH 85757 Karlsfeld Germany Telephone 49 81 31 59 57 290 www arthrex de LM0652D Arthrex Inc All rights reserved ArthraxSo Adapteur Power System User s Guide TABLE OF CONTENTS TABLE OR CONTENTS sisssesisescccecsceseycecesesteessdeseetecaseesstuacaevecsasesdeceassesecacscaseesecsavetsvesdessocvageesededsteiecensssacceessecbeddececeovsescessssencesese 2 1 0 READ THIS FIRS P csssccisessccisccesetscecisdevsceissscsesecsevsensecsessuevescscsssuesedessossuancoecesuecovessdeecevscesscuevesuasessusecesssseeesecdesvensesesseocse 4 1 1 IMPORTANT SYMBOLS AND CONVENTIONS ss ssesssssssetesesseiitttstttttt tten rt ttet tes ttt renees EEEE EEESPEEEEEEESEENEEEEEEPEEEEEE ESSEEN EEEE Eeen E EErEE ene 4 1 2 SHIPPING UNPACKING AND WARRANTY INFORMATION ccccescsscecesssscsceccessessesceeseseseeeseceseessesseeeseeeessescecseeessn
6. IED WARRANTIES THEN SUCH IMPLIED WARRANTIES SHALL BE LIMITED TO THE CONTENTS AND DURATION OF THIS EXPRESS WARRANTY 25 ArthraxSo Adapteur Power System User s Guide 26 11 0 Repair Policy Contact Arthrex for a Return Authorization Number and instructions prior to returning the device 12 0 Electromagnetic Emissions TABLE 13 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS The AR 8300S Shaver System is intended for use in the electromagnetic environment specified below The customer or the user of the AR 8300S Shaver System should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance _ The AR 8300S Shaver System uses RF energy only for its internal function RF emissions i D 3 CISPR 11 Group 1 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class A The AR 8300S Shaver system is suitable for use in all establishments other CISPR 11 than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions Class A IEC 61000 3 2 n Voltage fluctuations flicker emissions Complies IEC 61000 3 3 TABLE 14 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The AR 8300S Shaver System is intended for use
7. N The bottom line is also used to display momentary status or error messages 4 2 Console AR 8300 Oscillation Mode Adjustment e The AR 8300 console with Revision 5 00 00 or higher software has three different cas oscillation modes Standard STD Efficient EFF and Aggressive AGG The current IT mode will be shown in the bottom line of the display as either STD EFF or AGG when kaf the AR 8300 console is powered up and an accessory shaver handpiece is installed To change oscillation modes 1 Press and hold speed up and speed down buttons for 3 seconds 2 When the program menu appears press speed up to change the mode a The menu display will cycle between the three modes from Standard to Efficient to Aggressive then back to Standard 3 Once the desired oscillation mode is displayed press speed down to save the selected mode and exit the program menu 4 3 Accessory Handpiece Speed Limits and Deltas The console supports unique accessory handpiece motor speed limits defaults and speed increment decrement deltas These are defined below for the supported handpieces TABLE 11 ACCESSORY HANDPIECE SPEED LIMITS AND DELTA Handpiece Forward Reverse Speeds Oscillation RPM Speeds RPM Drill See 100 1400 Section N A N A N A 4 3 1 1 4 3 1 Drill Speed Table The drill is an exception to the regular increments in speed that the other attachments cycle through The drill supports the
8. SFS Standard Footswitch Connected No Tool No tool connected on channel Shaver Shaver connected Drill Drill connected Sag Saw Sagittal Saw connected SJ Shaver Shaver connected rpm Speed designation revolutions per minute EEPROM Reset Momentarily displayed first time microcontroller is programmed or if internal memory has faulted and is reset Motor Fault Momentarily displayed when motor fault condition occurs Qverload Momentarily displayed when motor over current condition occurs Self Test Fail Console has failed a critical power on test CRUISE NOT Momentarily displayed when cruise button pressed with tool that doesn t allow cruise ALLOWED control FWD or REV ONLY Momentarily displayed for tools that do not support OSC mode Lock Speed locked on cruise control TOGGLE NOT Momentarily displayed when toggle button pressed with two footswitches connected or ALLOWED no tool on opposite channel Agg Current mode Aggressive oscillation mode stopped CC ON Cruise control enabled about to lock Eff Current mode Efficient oscillation mode stopped English Programming mode Language set to English F R Current mode forward reverse stopped French Programming mode Language set to French Fwd Current mode Forward stopped Fwd gt Current status Motor is moving forward Gas Pedal Footswitch Momentarily displayed when gas pedal footswitch connected German Programming mode Languag
9. Speed Increase Decrease switches 9 Handpiece 2 Operator Display 10 Handpiece 2 Handpiece Receptacle 11 Handpiece 2 REVERSE Switch 12 Handpiece 2 OSCILLATE Switch 13 Handpiece 2 Footswitch Receptacle 14 Handpiece 2 FORWARD Switch 15 AC Mains POWER switch Abtei Adapteur Power System User s Guide 2 2 4 AR 8300 Rear Panel With Software 5 01 00 or Higher Figure 4 shows the rear panel of the console Features and symbols are identified in Table 4 FIGURE 4 REAR PANEL OF CONSOLE WITH SOFTWARE 5 01 00 OR HIGHER REF AR 8300 ArthresSo til CE ces Arthrex Inc Arthrex Med Inst GmbH Naples FL 34108 USA 85757 Karlsfeld Germany TABLE 4 REAR PANEL ELEMENTS ELEMENT ELEMENT NAME NUMBER Main Power Input Plug Comply with Operating Instructions Symbol Model Number Fan Protection Plate Type BF Splash Proof Symbol Serial Number Label Address Equipotential Bonding Pin Equipotential Bonding Symbol Fuse holder for the Power Entry Module CG See eub L n ra ArthraxSo Adapteur Power System User s Guide 2 2 5 AR 8300 Display Messaging A listing of informational and error messages is shown in Table 5 TABLE 5 AR 8300 DISPLAY MESSAGING MESSAGE EXPLANATION Arthrex Power on message Handpiece display APSIT Power on message Handpiece 2 display INACTIVE Handpiece disabled DFS Digital Footswitch Connected GFS Gas Pedal Footswitch Connected
10. acement or repair of any Equipment which Arthrex s examination shall disclose in its sole discretion to be defective or inoperative and will be conditioned upon Arthrex s receiving written notice of any alleged nonconformity or defect during the applicable warranty period and the return of defective products to Arthrex F O B Arthrex s facility If Arthrex determines that any product or service is not defective or that Arthrex is not liable for the defect the Customer will be notified thereafter Arthrex will repair or replace such product upon the Customer s written consent and at prevailing prices Arthrex may in its discretion provide reasonable use of loaner Equipment while repair or replacement is underway This warranty applies only to the original Customer and is not transferable except at the discretion of Arthrex Repairs and replacements made under this warranty are not warranted beyond the remainder of the warranty period ARTHREX S LIABILITY SHALL BE LIMITED SOLELY AT ARTHREX S OPTION TO REPAIR OR REPLACEMENT OF THE GOODS OR COMPONENT PARTS NOT MEETING THE QUALITY AND SPECIFICATIONS WARRANTED THERE ARE NO WARRANTIES IMPLIED OR STATUTORY INCLUDING THE WARRANTIES OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE OR INTENDED USE NON INFRINGEMENT OR ARISING OUT OF A COURSE OF PERFORMANCE DEALING OR TRADE USAGE THAT EXTEND BEYOND THIS EXPRESS WARRANTY IN THE EVENT THAT APPLICABLE LAW PREVENTS THE DISCLAIMER OF ANY IMPL
11. aeseeess 4 1 3 IMPORTANT SAFETY INFORMATION 5 2 0 PRODUCT DESCRIPTION sneren aE AEE EEEO LEOTA ESES ERRES 5 2 1 FUNCTIONAL DESCRIPTION AND INTENDED Up 5 2 2 PRODUCT FPA TURES ss sisi R ee auidedvsdedsssusss ra a a andes Eege Eo EEA ANERE EAEE EAEN 6 2 2 1 AR 8300 Console Front Panel cccecccccccccccccccccccccccccccceccceeeseesusessteceusvscsstsessnsnsssaccsseeecccccceeecceeceseccecceeeeeeeeeeeeeeeeneeeenss 6 2 2 2 AR 8300 Console Rear Panel 7 2 2 3 AR 8300 Console Front Panel With Software 5 01 00 or Higher c ccccccccccccesseseseeeseeeseeseeseeeeseeseesseseesseteetentenees 8 2 2 4 AR 8300 Rear Panel With Software 5 01 00 or Higher cccccccccccecceccecseeescuseeetseceeeeesseseceseeseeeceseeseeecersnteersneeteeees 9 2 2 5 AR 8300 Display E 10 2220 Slandard FOOLS WI CM seraient teenie ewes ba nswk e E te sehceyiae teas a EE NEEE EEEE AE e Ll 2 3 TECHNICAL SPEGIFIGA TIONS i cs c0ias52 scedeg3seheessceadseaees sgasedesaccesesoendagesedeacedusedechsacasadeandesseas ovjseedsbesdusddeedengsdoobaergeisesteaesees 11 23A sCGOMS ON EE EE 1l 23 2 Standard EE 12 23 3 Ambient Conditions for Operation 12 2 3 4 Ambient Conditions for Storage in shipping packaging ecccccccccceccesecesceseeeseenseeseeseceecnseeeenseeueceseseeeeaeeeeeeeenseeatens 12 3 0 S A H DI EE 12 3 1 HOW rog rrUpmpgCoNsoLt EEEE ERSEN EEEEEEEEEEEEEEEESEEE NEEESE ENEE EE ESEESE EEEE Seen EEEE 12 3 2 AC POWER SAFETY CONSIDERATIONS cccsccscccessssssccsscccssssseescessss
12. al important and useful information using these symbols and conventions Your familiarity with these symbols and conventions is required WARNING The WARNING symbol identifies critical information that must be followed precisely to avoid injury or death The WARNING symbol is the most important safety symbol A The CAUTION symbol identifies important methods and procedures that must be followed to avoid damaging the device or causing it to malfunction NOTE This symbol identifies useful information that can simplify the setup and operation of this device 1 2 Shipping Unpacking and Warranty Information Prior to use in a surgical procedure carefully unpack and inspect the components for any sign of damage that may have occurred during shipping If shipping damage is suspected notify Arthrex or any authorized Arthrex distributor immediately Any such damage could compromise patient safety If transport or first installation damage is not reported within seven business days of receiving the device the warranty could be rendered void Refer also to our General Terms of Business Arthrex assumes a warranty to the first purchaser for a twelve month period with regard to defects or failure of its medical devices All defective products covered by the warranty are repaired or replaced free of charge by Arthrex at Arthrex s discretion The warranty does not cover any damage caused by unlawful use or improper handling of a particu
13. cessory handpiece cable connects and locks to the console to prevent accidental separation during use To avoid damage disconnect the accessory handpiece by pulling on the cable connector shell plug only 19 ArthraxSo Adapteur Power System User s Guide 5 0 Cleaning and Disinfection 5 1 Console AR 8300 Clean and disinfect the console with a commercially available surface disinfectant AA Always comply with the instructions issued by the manufacturer of the disinfectant A NEVER clean the console receptacles with liquid cleaners Remove dust if necessary with dry compressed air 5 2 Footswitches Refer to Multifunction Wireless Footswitch Operator s Manual for additional cleaning instructions Clean the footswitch with an enzymatic cleaner without subsequent acid neutralization Rinse the footswitch thoroughly after cleaning After cleaning disinfect the footswitch with a commercially available surface disinfectant Thoroughly rinse the footswitch under lukewarm water A Always comply with the instructions issued by the manufacturer of the disinfectant A NEVER allow the console receptacles to have any contact with liquids Remove dust or moisture if necessary with dry compressed air ONLY dry connectors should be plugged into the console 5 3 Accessory Cable Clean the cable with an enzymatic cleaner without subsequent acid neutralization Rinse the cable thoroughly after cleaning After cleaning disinf
14. csseeseeeecsesescesessesesessesssseessesesesessesettenaes 19 4 6 ACCESSORY HANDPIECES ccccccccsscssssscssccssesscsscccsessscseseceesesseescecseseneeescecscecsesssececsesssssseceesesussscecsessessceceesentseeeeeeees 19 5 0 CLEANING AND DISINFECTION oessscesesscsssovsssesccessesscessscsseessscossecsesesocstdesccssssbeeessscceseaviesesoosevseossssasteasdcodedeseccseseees 20 5 1 CONSOLE EE WE 20 5 2 ROOTS HE E EE 20 5 3 ACCESSORY EE 20 5 4 ACCESSORY Engele 21 Abtei Adapteur Power System User s Guide 6 0 SS HR CTIE KE WH LEE 21 6 1 INCGESSORN EE 22 6 2 ACCESSORY HANDPIEGES scsisedsscodevecinscesicathseandiniegs gen EAER ER ANNEE EE RENERE ORA ehtadestudeush clusseed aaiuscsdaesandoneesa caneseentes 22 7 0 TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY AGENTS ccssscsssssssscssccssscssscccssccssesssscsssccssscssones 23 8 0 MAINTENANCE EE 23 9 0 TROUBLESHOOTING vcvsssseccsscssesscscdocossdacssocceossde ssosensscnddsetsnnteecvoesstesscesbassacsccecesnccesobetesssusceoosudeddesdedcsessscoussecececstorsess 24 9 1 REPLACING THE FUSES 6 ssscccavsazs cvectadusessetevai se se Oaa EEEE o E EEEE EE S EERIE TENE EIEEE ASE EEE EEEE EE SNOET EET E EERE 24 9 2 TROUBLESHOOTING INTERFERENCE TO OTHER DEVICES sssesssessssseeetstetserertstststetsrerstetstsrststttststeteeesrnretetesrererst 25 10 0 LIMITED WARRANTY sscscsscssccssccascscicecsccceccatescsesnsceustevscascosstsevcancuestscesesesectesecetscosseesvoceatessseueseusceevoncceedaucuesescsscvsae
15. ct with orthopaedic surgical instruments are those of low TSE infectivity However particular precautions should be taken when handling instruments that have been used on known suspected or at risk patients References ANSI AAMI ST46 Good Hospital Practice Steam sterilization and sterility assurance 8 0 Maintenance The Adapteur Power System requires no routine maintenance There are no operator repairable components and no scheduled intervals for mechanical inspection If any system component malfunctions please contact Arthrex 23 ArthraxSo Adapteur Power System User s Guide 9 0 Troubleshooting If problems occur after cleaning after transporting to other operation sites or when there is a change of operating staff simple remedies are listed in Table 12 TABLE 12 TROUBLESHOOTING FAULTS AND THEIR CAUSES AND REMEDIES Unit does not power on 1 Check the main power plug and wall receptacle 2 Check the fuses 3 Send in for repairs Handpiece does not work Check whether the connector is plugged into the correct channel receptacle Check that both connectors are plugged in properly Liquid in the receptacle or connector Dry thoroughly Connector is damaged Replace the cable Footswitch is defective operate the device using the console unit Footswitch is functional replace the footswitch Handpiece is too hot after sterilization Allow it to cool down per the WARNING in Section 6 0 Handpiece over curr
16. d for proper cleaning and disinfection of instruments prior to sterilization Sterilization capabilities cleaning disinfecting handling and storage of instrumentation are the responsibility of qualified facility user personnel Reusable accessories that are provided non sterile may be sterilized by one of the following methods Gravity displacement cycles e 270 F 275 F 134 C exposure time 18 minutes minimum e 250 F 121 C exposure time 60 minutes Prevacuum cycle e 270 F 275 F 134 C 5 minutes 21 Arbeit Adapteur Power System User s Guide Sterilizers vary in design and performance characteristics so cycle parameters should always be verified against the sterilizer manufacturer s instructions for the specific sterilizer and load configuration being used It is recommended that the user perform appropriate validation tests Drying It is recommended to use a dry cycle of a minimum of 4 minutes Cooling The device must be adequately cooled after being removed from the sterilizer 6 1 Accessory Cable A After sterilization in the autoclave let the cable cool down slowly NEVER use cold water to cool the cables down as this can damage the cable connections and seals A Liquid on the cable receptacle or connection of the handpiece can cause damage to the device Before connecting the cable ensure the receptacles are clean and dry WARNING After autoclaving the cable is VERY HOT Ca
17. dentified in Table 1 FIGURE 1 FRONT PANEL OF CONSOLE A BR D E F H l J L M O C G K N TABLE 1 FRONT PANEL ELEMENTS FEATURES SYMBOLS 1 Handpiece 1 Speed A Protection plate TYPE BF Increase Decrease switches 2 Handpiece 1 Operator Display B Handpiece 1 ID Label 3 Handpiece 1 Handpiece Receptacle C Handpiece 1 Speed Adjust 4 Handpiece 1 REVERSE Switch D Handpiece 1 Receptacle 5 Handpiece 1 OSCILLATE Switch E Handpiece 1 Classification 6 Handpiece 1 Footswitch Receptacle F Handpiece 1 Direction Adjust 7 Handpiece 1 FORWARD Switch G Footswitch 1 Receptacle 8 Handpiece 2 Speed H Footswitch 1 Classification Increase Decrease switches 9 Handpiece 2 Operator Display I Handpiece 2 ID Label 10 Handpiece 2 Handpiece Receptacle Handpiece 2 Speed Adjust 11 Handpiece 2 REVERSE Switch Handpiece 2 Receptacle no ArthrexSo Adapteur Power System User s Guide 2 2 2 FEATURES SYMBOLS 12 Handpiece 2 OSCILLATE Switch Handpiece 2 Classification 13 Handpiece 2 Footswitch Receptacle Handpiece 2 Direction Adjust 14 Handpiece 2 FORWARD Switch Footswitch 2 Receptacle 15 AC Mains POWER switch Footswitch 2 Classification ozzZr AR 8300 Console Rear Panel Figure 2 shows the rear panel of the console Features and symbols are identified in Table 2 FIGURE 2 REAR PANEL OF CONSOLE rd N EI DN a A REF AR 8300 Aber ttil C Eoss EC REP H H Arthrex Inc Arthrex Med Ins
18. e disconnect the footswitch by pulling on the cable connector shell plug only 4 5 Footswitches 4 5 1 Standard Footswitch The Speed Increase button adjusts the speed in the positive direction only Each time the switch is actuated the speed is adjusted as shown in the Table 11 When the maximum speed is reached the next time the switch is actuated the speed setting cycles and returns to the minimum setting If multiple switches are detected simultaneously then the switch commands are ignored If the Speed Increase switch is continuously actuated for more than 1 0 seconds then the speed auto increments accordingly The speed setting will not wrap when auto incrementing Release the Speed Increase button and then press it again to get the speed setting to cycle to the minimum setting again 4 5 2 Gas Pedal Footswitch The Forward Reverse and Oscillate pedals linearly adjust the speed When the pedal is actuated it returns an analog signal that is converted to a corresponding RPM between the minimum and maximum speed of the attachment that is connected 4 5 3 Multi Function Footswitches Available as optional accessories both the Wireless and Corded Multi Function Footswitches can operate as either a Standard Footswitch or as a Gas Pedal Footswitch as described in the preceding sections Function selection is made by pressing the button on the Multi Function Footswitch labeled GFS SFS 4 6 Accessory Handpieces A The ac
19. e motor will rotate in a forward direction first when oscillation is entered If any other combination of button pedal activations is detected simultaneously then the commands are ignored This operation applies to the console front panel buttons as well as to the supported footswitch pedals 4 4 3 Cruise Control The cruise control function is engaged from the Gas Pedal Footswitch which is available as an optional system accessory Cruise control operation is as follows 1 CRUISE SET When you select the Cruise Control Switch the Cruise function becomes ARMED signified by a single audible 1 second alarm beep but the LOCK IN period does not start until one of the three pedals is actuated If a pedal is not actuated within 15 0 seconds then the Cruise function becomes DISARMED signified by a single audible 1 second alarm beep If the Cruise switch is actuated on an attachment that does not allow cruise control an error 17 ArthraxSo Adapteur Power System User s Guide alarm beep occurs 3 fast tones and a momentary message is displayed CRUISE NOT ALLOWED 2 CRUISE LOCK The LOCK IN period lasts for up to 15 0 seconds During the LOCK IN period the operator adjusts the speed and must hold the pedal steady for 3 seconds in order for the LOCKED state to occur Steady is defined as 500 RPM for forward reverse and 400 RPM for oscillation If the pedal is held steady the Shaver Console emits an audible double alarm beep
20. e set to German Italian Programming mode Language set to Italian No Footswitch Momentarily displayed when footswitch disconnected Osc Current mode oscillation stopped Osc Current status Motor is oscillating Prog Mode BRIGHTNESS Console is in programming mode Set the display brightness Prog Mode LANGUAGE Console is in programming mode Set the language Programming mode instructions to change function currently LANGUAGE or BRIGHTNESS Rev Current mode Reverse stopped Rev lt Current status Motor is moving in reverse Run gt Current status Motor is running for saw Spanish Programming mode Language set to Spanish Standard Footswitch Momentarily displayed when standard footswitch connected Std Current mode Standard oscillation mode stopped Use Speed Increase to set Programming mode instructions to change parameter Rev key changes mode 10 Abtei Adapteur Power System User s Guide 2 2 6 Standard Footswitch Figure 5 shows the Standard Footswitch Features and symbols are identified in Table 6 FIGURE 5 STANDARD FOOTSWITCH s BE TOGGLE 3 ARTHREX and AR 6310 ADAPTEUR POWER SYSTEM II a 5 TABLE 6 ELEMENTS OF THE STANDARD FOOTSWITCH ELEMENT ELEMENT NAME NUMBER Cable Speed Increase Button Toggle Button Forward Pedal Oscillating Pedal Reverse Pedal Amn bb La FA 2 3 Technical Specifications 2 3
21. ect the cable with a commercially available surface disinfectant Thoroughly rinse the cable under lukewarm water See Section 6 0 for sterilization information A Always comply with the instructions issued by the manufacturer of the disinfectant 20 Abtei Adapteur Power System User s Guide A NEVER allow the console plug pins to have any contact with liquids Remove dust or moisture if necessary with dry compressed air ONLY dry connectors may be plugged into the console 5 4 Accessory Handpieces Remove any accessories in the device such as shaver blades saw blades or drill bits Open the suction control fully if applicable Clean the handpiece with an enzymatic cleaner without subsequent acid neutralization Clean the suction control connection with a cleaning brush if applicable Rinse the handpiece thoroughly after cleaning Disinfect the handpiece with a commercially available disinfectant Thoroughly rinse the handpiece under lukewarm water See Section 6 0 for sterilization information A Always comply with the instructions issued by the manufacturer of the disinfectant A NEVER place the shaver handpiece in Cidex or other aldehyde disinfectant solutions A NEVER allow the console plug pins to have any contact with liquids Remove dust or moisture if necessary with dry compressed air ONLY dry connectors may be plugged into the console 6 0 Sterilization Sterilization does not eliminate the nee
22. enscecendsusecactasandvoantatpaceveendsiosiastensescacsassedealacpiteeeeads 10 TABLE 6 ELEMENTS OF THE STANDARD FOOTSWITCH ssscsssssssssssssesssessceocsnscensenscessesseessssacenscoeseneeessessesssonsesneenesonsseneseaees 11 TABLE 7 AR 8300 CONSOLE SPECIFICATIONS REENEN 11 TABLE 8 STANDARD FOOTSWITCH SPECIFICATIONS sseseesessessresestsseeesetsrrsersestrtestrseseeseestrserteetistsesesntreestestnseseesernterestestnstsres 12 TABLE 9 AR 8300S AMBIENT CONDITIONS FOR OPERATION sssssssesesssestsrereeseststststerestttsteetstststetstststetestsrstetentsrsteeererts 12 TABLE 10 AR 8300S AMBIENT CONDITIONS FOR STORAGE s sssssssesssstsrtsestssisttttstettttisttsttsinttstnststesttsttsrstestusentesttantsrstennn 12 TABLE 11 ACCESSORY HANDPIECE SPEED LIMITS AND DELTA 16 TABLE 12 TROUBLESHOOTING FAULTS AND THEIR CAUSES AND REMEDIES sessssiesisrssrssteretrttertsessrsttsrstestnstntesesresrstese 24 TABLE 13 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS csscsseseseeseseeeeseeeeeeeeeeseseeees 26 TABLE 14 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY s sssssssssssosieosisseriseosireereeene 26 TABLE 15 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY ssssssssssssissesestesessesstseeseeseseeses 27 ArthraxSo Adapteur Power System User s Guide 1 0 Read This First 1 1 Important Symbols and Conventions The Adapteur Power System II User s Guide identifies critic
23. ent is detected Allow 30 seconds for the console to re set the affected channel Defective handpiece Send in for repairs Motor runs but shaver blade does not work Not inserted properly Insert the shaver blade so that it engages and close the locking mechanism fully Hub is damaged Replace the shaver blade Sleeve is bent Replace the shaver blade Suction connection is clogged Rinse with a syringe Shaver blade or burr is clogged Clean with a brush Suction Control is closed Open Suction Control Suction control is damaged Send in for repairs Check the connector from the footswitch to the control unit Liquid in receptacle or connector Dry thoroughly Footswitch defect Send in for repairs Check that both connectors are plugged in properly Check the connector with another handpiece Connector is damaged Replace Defective handpiece Send in for repairs No suction System runs with the control unit but not with the footswitch Connected handpiece not shown on display Be e eh DN ae If the problems persist disinfect the Adapteur Power System and send in to Arthrex using the original packaging Always send the corresponding handpiece together with the console footswitch and cable Please enclose a brief explanation of the detected malfunction Refer to Section 11 0 for more information 9 1 Replacing the Fuses The mains fuses can be replaced as follows 1 Disconnect the device from the AC mains 2 Open the fu
24. epresentatives if in their professional judgment they require a more comprehensive surgical technique 3 2 AC Power Safety Considerations The AR 8300 is powered by a medically rated universal AC input switching power supply which allows the console to be connected to any local AC mains outlet provided that you use the appropriate plug and a reliable ground conductor Two power cords are supplied by default with the AR 8300 one for the electrical standards of the U S and one for the electrical standards of Germany Contact your Arthrex representative if you need a power cord that must meet the electrical standards of another country The console has been designed to meet power saving guidelines The console has an AC mains switch on the front panel When the AC mains switch is OFF no electrical power is drawn by the console When the AC mains switch is ON the console automatically executes a brief series of self diagnostic tests Upon successful completion of these self diagnostic tests the console displays the name and model number If the tests discover a problem you see 12 Arthrexo Adapteur Power System User s Guide the problem displayed in the display Refer to Table 5 for a listing of AR 8300 Display Messaging In the event of an AC power interruption the console can run continuously without a fault for up to 10 milliseconds If AC power failure lasts for longer than 10 milliseconds the system will return to default set
25. epress the Handpiece 1 Reverse switch The system is ready for use 4 0 Operation 4 1 Console AR 8300 Speed Adjustment To power on the console toggle the POWER SWITCH button to the ON position The console initiates a series of self diagnostic checks Figure 6 shows the layout for the two independent displays one display for each attachment channel The two displays operate exactly the same for their respective channel FIGURE 6 LAYOUT OF THE AR 8300 DISPLAY Channel Inactive l Channel Inactive Tool Name or Pedal Type Tool Name or Pedal Type ANDPIECE 1 Sag Saw INACTIVE Shaver 18000RPM F R 8000RPM FWD gt Control Control Status Status Status Status The top line is split into two areas The left side displays the name of the device and the right side displays either the footswitch attached or blank if no footswitch or INACTIVE if the channel is disabled see Section 4 3 4 Toggle Function The bottom line is divided into three areas 1 Speed which reflects the RPM of the output shaft for the device attached 15 Arbeit Adapteur Power System User s Guide 2 When the motor is stopped the mode is Forward FWD or Reverse REV or the current Oscillate Mode STD EFF or AGG as described in section 4 2 When the motor is running the direction is Forward FWD Reverse REV or Oscillating OSC 3 Cruise Control Status Lock or Cruise Control ON CC O
26. esseesscccsesenesssecececssessssssesesssssccesecenssseceeeeesesaseseess 12 3 3 HOW TO SET UP A FOOTS WITCH EE 13 3 4 HOW TO SET UP THE SHAVER HANDRIRCES estt E reee PEPEE EEESEEEEEEEES EEEE E EASES EEEE Eneee ereenn 14 3 5 HOW TO SET UP OTHER ACCESSORY HANDPIECES ccccecsscecesesscsceccesecsssssesecsesesescscceseeesssseseceesesssssecesessssseseeeeeeensaeas 14 3 6 HOW TOADIUST THE SYSTEM sssr dees vssbie cosets ad deve qangaua sdesesnusoaseboabeveaescede covets sdbsea cedsceceyersededssetasagedsedesancaude vbagiaceacs deus 14 3 6 1 Brightness ACUSUMCHE Eegeregie E AEE EEEE eE 14 3 62 Language EE 15 4 0 OPERA TION ME 15 4 1 CONSOLE AR 8300 SPEED ADIUSTMENT 15 4 2 CONSOLE AR 8300 OSCILLATION MODE ADIUSTMENT 16 4 3 ACCESSORY HANDPIECE SPEED LIMITS AND DELTAS ssssssssssssssssssessesessriesseressrrssseressersssersssosssstesseorssneerssoessnresssrers 16 AS Eer 16 CR EE TEE 17 4 4 ATTACHMENT MOTOR CONTROL ies cscatcssssucessbsejateve esoe dree Seen EENS REENEN EERSTEN dE EES 17 E EE EE 17 4 4 2 Forward Reverse and Oscillate Mode 17 AA 3 Cruise EE 17 AAA Topole DEE TEE E EIENEN NEES AO E ET OE EE EE enteatiicone 18 4 5 TXELOA RSA DE E EE 19 4 5 1 Standard Footswitch viiccccccccccssecssscccsscccccccccccccccccecesecesuesessestuseestesvseesvsnssssnccssccccncccesecceecceeeeceeeeeeeeseeeeeeeteeeeeeeeteeeseees 19 432 Gas Pedal EE 19 4 33 M lti Function FOOtsWitches c cccccccccccccccccccccesscsssssssesssssssvsnssssssssnssssnscssccsc
27. footswitch or by the front panel switches The AR 8300 console is designed for continuous operation The motorized handpieces are individually protected by a resetting thermal fuse In the event of a motor overload fault e g excess current the fuse heats up and the device is de activated When the fault is removed and the thermal fuse cools down typically about 30 seconds operation resumes retaining the pre failure settings The cable and all handpieces can be sterilized This means that the handpieces can be changed during the surgical procedure without endangering surgical sterility The Adapteur Power System AR 8300S includes AR 8300 Console with power cord Standard Footswitch Two Shaver Handpieces User s Guide Optional Accessories e Gas Pedal Footswitch e Corded Multi Function Footswitch ArthraxSo Adapteur Power System User s Guide e Wireless Multi Function Footswitch e Accessory Handpiece Cable e Drill Handpiece with key for Jacobs chuck e Sagittal Saw Handpiece with wrench Save the packaging for later transport of the device WARNING This device is to be used by or only 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 2 Product Features 2 2 1 AR 8300 Console Front Panel Figure 1 shows the front panel of the AR 8300 console Features and symbols are i
28. ign and they engage easily 13 ArthraxSo Adapteur Power System User s Guide 3 4 How to Set Up the Shaver Handpieces AA Only use shaver handpieces and cables that have been developed by Arthrex specifically for the Adapteur Power System II Insert the 15 pin connector from the handpiece into the handpiece receptacle of the console so that the red dots on the connector and receptacle align and engage easily 3 5 How to Set Up Other Accessory Handpieces A Only use handpieces and cables that have been developed by Arthrex specifically for the Adapteur Power System II Other accessory handpieces are available for use with the Adapteur Power System II and may require the use of an accessory cable Specific instructions for use of a particular accessory handpiece are packaged with the handpiece The procedure for setting up the handpiece and accessory cable is described below Insert one end of the accessory cable connector 13 pin into the cable receptacle of the accessory handpiece so that the red dots on the connector and receptacle align and engage easily Connect the other end of the accessory cable to the handpiece receptacle of the console so that the red dots on the connector and receptacle align and engage easily 3 6 How to Adjust the System A Do not attach handpiece s or footswitch s during Self Test or during the following Programming Modes 3 6 1 Brightness Adjustment This display allows the operator to vary the d
29. isplay brightness by using the FORWARD and REVERSE switches These switches increment or decrement the brightness and cycle around from the minimum to the maximum setting 1 Press and hold the Handpiece 2 FORWARD and REVERSE Switches during power up 2 Depress the Handpiece 1 Speed Increase or Speed Decrease Switches to increase decrease brightness setting respectively 3 Once desired brightness is reached depress the Handpiece 1 Reverse switch twice and system is ready for use 14 Abtei Adapteur Power System User s Guide 3 6 2 Language Selection This display allows the user to select one of five languages The language is selected by using the FORWARD and REVERSE switches The switches will scroll through the selected choices and wrap around at the beginning and end of the list You can view the display text in English French German Italian or Spanish The default language is English To select a different language follow these steps NOTE Reference Figure 1 or Figure 3 for a diagram of front panel Do not switch the unit off or disconnect the main power plug until final step is finished otherwise all changed settings are lost 1 Depress the Handpiece 2 FORWARD and REVERSE switches during power up 2 Depress the Handpiece 1 Reverse switch once to enable Language selection 3 Depress the Handpiece 1 Speed Increase or Speed Decrease switches to select the desired Language 4 Once you choose the Language d
30. lar product The warranty becomes invalid when Arthrex products are changed in any way or repairs are performed by any party other than Arthrex Arthrex will answer any questions referring to the quality reliability and or shelf life of any product identified in this User s Guide Artbteie Adapteur Power System User s Guide 1 3 2 0 2 1 Important Safety Information WARNING This device is to be used by or 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 A U S Federal Law restricts this device to use only by or on order of a physician A DO NOT under any conditions or for any reason open the console AR 8300 or any other shaver accessory NOTE Read this User s Guide thoroughly before attempting to operate the device and retain for future reference Users of this device are encouraged to contact their Arthrex representatives if in their professional judgment they require a more comprehensive surgical technique Product Description Functional Description and Intended Use The Arthrex Adapteur Power System II is a multi functional system designed for many different orthopedic uses The system is microprocessor controlled and can operate several different handpieces Handpieces are connected to the console by means of a cable and are operated by a waterproof
31. m User s Guide input lines 60 dip in Ur for 5 cycles uninterruptible power supply 50 60 Hz magnetic field IEC 61000 4 8 IEC 61000 4 11 30 Reduction 70 Ur 500ms 30 dip in Ur for 25 cycles 95 Reduction 5s lt 5 Ur 95 dip in Ur for 5 sec Power frequency 3 A m 3 A m 50 amp 60 Hz Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Note Uris the a c mains voltage prior to application of the test level TABLE 15 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The AR 8300S Shaver System is intended for use in the electromagnetic environment specified below The customer or the user of the AR 8300S Shaver System should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz Portable and mobile RF communications equipment should be used no closer to any part of the AR 8300S Shaver System including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 17P12
32. on Toggle is allowed when there is one footswitch connected and two handpieces connected When the user presses the toggle switch and the conditions are met for a valid toggle a long alarm beep indicates the footswitch has been toggled and now the user can control the opposite handpiece with the footswitch Additionally the original handpiece that the user was previously controlling becomes inactive which means it cannot be operated from either the footswitch or front panel controls When the user presses toggle again the footswitch goes back to controlling the original handpiece and the opposite handpiece becomes inactive When a toggle function occurs the footswitch indicator moves to the display channel that the user is controlling and the other channel is shown as INACTIVE The toggle function is not allowed if there are two footswitches installed An error alarm beep occurs and the momentary message TOGGLE NOT 18 Abtei Adapteur Power System User s Guide ALLOWED is displayed when the user attempts to toggle with two footswitches installed The toggle function is not allowed if only one handpiece is attached An error alarm beep occurs and the momentary message TOGGLE NOT ALLOWED is displayed when the user attempts to toggle when there is only one handpiece attached to the console Ah The footswitch cable connects and locks to the console to prevent accidental separation during use To avoid damag
33. reless handling can result in burns 6 2 Accessory Handpieces A After sterilization in the autoclave let the handpieces cool down slowly NEVER use cold water to cool the handpieces as this can damage the electronic components and seals A Liquid on the cable connector of the handpiece can cause damage to the device Before connecting the cable ensure that the receptacles are clean and dry WARNING After autoclaving the handpieces are VERY HOT Careless handling can result in burns The following special instructions are to be observed when sterilizing accessory handpieces A Open the suction control completely to ensure proper circulation if applicable A Open the chuck completely to ensure proper circulation if applicable 22 Abtei Adapteur Power System User s Guide AA Do not sterilize a handpiece with accessories such as shaver blades drill bits or saw blades attached 7 0 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 Agents The agents for transmission of Creutzfeldt Jakob Disease are believed to be resistant to normal processes of disinfection and sterilization and 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 conta
34. se speeds only 100 300 500 900 and 1400 RPM NOTE While operating handpieces settings can be changed without risk of damaging the motor or console 16 Artbteie Adapteur Power System User s Guide WARNING If defibrillation of the patient is required or the surgical process entails working with high frequency instruments ensure that the patient is not in direct contact with the equipment 4 3 2 Front Panel Switches The Speed Increase and Speed Decrease panel switches adjust the speed Each time the switch is actuated the speed is adjusted as shown in Table 11 If multiple switches are pressed simultaneously the switch commands are ignored If the Speed Increase or Speed Decrease switches are continuously actuated for more than 1 0 seconds then the speed will auto increment or decrement accordingly The values will not exceed the minimum and maximum values defined for the attachment 4 4 Attachment Motor Control 4 4 1 Definition of Direction The definition of direction as viewed looking from the proximal to the distal of the shaver handpiece I Reverse Counterclockwise CCW II Forward Clockwise CW M Oscillate CW then CCW IV Stop No rotation 4 4 2 Forward Reverse and Oscillate Modes Reverse Forward and Oscillate buttons pedals select which direction the motor rotates If the Reverse and Forward buttons pedals are detected simultaneously then the motor defaults to oscillation mode Th
35. se tray in the AC inlet by pulling out on the tabs 3 Replace the fuses with the proper values as noted on the rear panel 4 Push the fuse holder back into the AC inlet 24 Abtei Adapteur Power System User s Guide A Always use fuses with the correct values to avoid allowing overcurrent to enter the system NOTE The AR 8300 console incorporates a universal AC input power supply A voltage selection switch is not required 9 2 Troubleshooting Interference to Other Devices To correct the interference try one or more of these suggestions A Reorient or relocate the receiving device Increase the separation between devices A Connect the device into an outlet on a circuit different from that to which the other device s are connected A Consult the manufacturer or field service technician for the receiving device for guidance 10 0 Limited Warranty For a period of one 1 year after delivery of the Equipment and subject to the terms hereof Arthrex warrants the Equipment to be free from manufacturers defects in material and craftsmanship under normal use and service The Warranty does not apply to any Equipment that has been repaired serviced or altered outside of the manufacturer s or Arthrex s facility or to Equipment that has been subjected to abuse misuse neglect accident or negligence in use storage or handling Arthrex s obligation and the Customer s sole and exclusive remedy is limited to the repl
36. ss 25 11 0 RRESIRROL Keeser 26 12 0 ELECTROMAGNETIC EMISSION S vicssscsccesiescescescccscdeacscossssseccesodteccscsedsectucseosessesssesisenssescsdestsesostavcssist esondsscseoasssais 26 13 0 CONTACT INFORMA TION cesicsscovacesscsccivscicscsenccctscccsesevedecnsnacecacacsnacesessevecedecconebeceeves doesuasseavsussoussesvenedesseasscedsaeeussess 28 13 1 COMPLIANCE INFORMATION EE 28 LIST OF FIGURES FIGURE 1 FRONT PANEL OF COoNSOLE NAAA tatn ESES ESENES ANENA E ESEA ESES ESES ENES En Ena nane ns naene sanee ne na 6 FIGURE2 REAR PANEL OF CONSOL Eisin aron i oa e A EENE ETE VENE AEE SE AEE EEE a NES H FIGURE 3 FRONT PANEL OF CONSOLE WITH SOFTWARE 5 01 00 OR HIGHER s sssssssessssesstsstsisststestesesetsrtsrstestnsenrestssresrsestete 8 FIGURE4 REAR PANEL OF CONSOLE WITH SOFTWARE 5 01 00 OR HIGHER cesceccesseeceesseeseceeeeseceeeesecesececeeaeceseeseeeaeeneeeneee 9 FIGURE 5 STANDARD FoOTswIrchH A AA A 11 FIGURE 6 LAYOUT OF THE AR 8300 DISPLAY EE 15 LIST OF TABLES TABLE 1 FRONT PANEL ELEMENTS cscscsscssssessesesesessesescesescessscessssesssesesaescsseucessseessuccseesesessesessesesaeseeseaesesaeecseeeeseeeeaesesaeeeeas 6 TABLE 2 REAR PANEL ELEMENT Sitsisisccsscesinesistea oiscstescaesaaseagoatdevecusest densa cdencedsa vas S santa sobesnaavegestessnes 7 TABLE 3 FRONT PANEL ELEMENTS EE A Rae AGAR aiden Se 8 TABLE 4 REAR EE E ER 9 TABLE 5 AR 8300 DISPLAY MESSAGING i c iccceckscceedinsisanscoseccessscanastsssasoucc
37. t GmbH Naples FL 34108 USA 85757 Karlsfeld Germany l 100 240V 50 60HZ 6 3A 76 3A 250V IPX1 eg 9 8 7 6 TABLE 2 REAR PANEL ELEMENTS ELEMENT ELEMENT NAME NUMBER 1 Main Power Input Plug Comply with Operating Instructions Symbol Model Number Fan Splash Proof Symbol Serial Number Label Address Equipotential Bonding Pin VG GE A GL RAUN Equipotential Bonding Symbol Fuse holder for the Power Entry Module ArthraxSo Adapteur Power System User s Guide 2 2 3 AR 8300 Console Front Panel With Software 5 01 00 or Higher Figure3 shows the front panel of the AR 8300 console Features and symbols are identified in Table 3 FIGURE 3 FRONT PANEL OF CONSOLE WITH SOFTWARE 5 01 00 OR HIGHER 1 27 By 4 D Fj 8 7 93 10 11 12 14 15 e i ch o ap Jj J EEEF b APSIl o TABLE 3 FRONT PANEL ELEMENTS FEATURES SYMBOLS 1 Handpiece 1 Speed A Handpiece 1 Receptacle Increase Decrease switches Handpiece 1 Operator Display Handpiece 1 Handpiece Receptacle Handpiece 1 REVERSE Switch 2 Footswitch 1 Receptacle 3 4 5 Handpiece 1 OSCILLATE Switch 6 7 8 Handpiece 2 Receptacle Footswitch 2 Receptacle gaw Handpiece 1 Footswitch Receptacle Handpiece 1 FORWARD Switch Handpiece 2
38. tings when AC power is restored WARNING If high frequency devices are in use or defibrillation of the patient is required ensure PE that the device is not in direct contact with the patient l a A This device has passed testing for EMI RFI radiation and susceptibility and kg EMC compatibility However if not set up and used in accordance with the instructions provided by Arthrex this device may cause interference to other devices in the near vicinity DO NOT stack or place equipment adjacent to the AR 8300 console if possible If such a configuration is necessary carefully observe the configuration in question to ensure that electromagnetic interference does not degrade performance 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 will result in patient and or operating room staff injury 3 3 How to Set Up a Footswitch A Only use footswitches that have been developed by Arthrex specifically for the AR 8300 Adapteur Power System II NOTE Setup for a footswitch is the same for all models The console will detect which version is attached and allow functions as appropriate Insert the 15 pin connector from the footswitch into the footswitch receptacle of the console so that the red dots on the connector and receptacle al
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