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Transmissible Spongiform Encephalopathy (TSE) Agents

Synergy Resection

User’s Guide

DFU-0213-7 Rev. 0

Page 40 of 50

8.0 Transmissible Spongiform Encephalopathy (TSE)

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 processes of disinfection and sterilization. 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.

References:

ANSI/AAMI ST79: Good Hospital Practice: Steam sterilization and sterility assurance.

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Содержание AR-8305

Страница 1: ...ccessories All operating personnel must read this User s Guide thoroughly prior to using this system and follow all safety warnings cautions and notes 0086 Arthrex Inc 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 www arthrex de DFU 0213 7 Revision 0 08 2019 2019 Arthrex Inc All rights reserved AR 8...

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Страница 3: ...TIONS 14 3 1 Console 14 3 2 Standard Footswitch 14 3 3 Ambient Conditions for Operation 14 3 4 Ambient Conditions for Storage in shipping packaging 14 3 5 Safety EMC and Regulatory Requirements 15 4 0 SETUP 16 4 1 How to Set Up the Console 16 4 2 AC Power Safety Considerations 16 4 3 Replacing the Fuses 17 4 4 Electromagnetic Compatibility 17 4 5 Basic Setup Procedure for the AR 8305 Console 18 4 ...

Страница 4: ...5 13 3 Cruise Control 32 5 13 4 Toggle Function 33 5 14 Footswitches 35 5 14 1 Standard Footswitch 35 5 14 2 Gas Pedal Footswitch 35 5 14 3 Multi Function Footswitches 35 5 15 Accessory Handpieces 35 6 0 CLEANING AND DISINFECTING 36 6 1 Console AR 8305 36 6 2 Footswitches 36 6 3 Accessory Cable 37 6 4 Accessory Handpieces 37 7 0 STERILIZATION 39 8 0 TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY TSE AGEN...

Страница 5: ...play One Tool Attached 20 Figure 5 Main Screen Display Two Tools Attached 20 Figure 6 Settings Menu Display Operation 21 Figure 7 Language Selection Display Operation 23 Figure 8 Oscillation Mode Selection Screen Operation 24 Figure 9 Footswitch Override Selection Screen Operation 25 Figure 10 Reset Defaults Screen Operation 26 Figure 11 Information Screen Operation 27 Figure 12 Single Handpiece S...

Страница 6: ...tion 23 Table 14 Oscillation Mode Display Operation 24 Table 15 Footswitch Override Display Operation 25 Table 16 Reset Defaults Display Operation 26 Table 17 Information Screen Display Operation 27 Table 18 Oscillation Mode Operation 28 Table 19 Two Handpiece Buttons Operation 29 Table 20 Accessory Handpiece Speed Limits and Delta 31 Table 21 Handpiece Accuracy 31 Table 22 Toggle Function 34 Tabl...

Страница 7: ...There are no user serviceable parts inside Removing the cover may introduce an electric shock hazard by exposing you to dangerous high voltages or other risks If the system malfunctions return it for service immediately 5 To avoid the RISK of electric shock this equipment must only be connected to a SUPPLY MAIN with protective earth ground 6 Do not have device in direct contact with patient if hig...

Страница 8: ...ramming Modes 9 Only use footswitches developed by Arthrex specifically for the AR 8305 Synergy Resection console 10 Only use shaver handpieces and cables that have been developed by Arthrex specifically for the Synergy Resection console 11 Only use handpieces and cables that have been developed by Arthrex specifically for the Synergy Resection The footswitch cable connects and locks to the consol...

Страница 9: ... receptacles are clean and dry 22 Open the suction control completely to ensure proper circulation if applicable 23 Open the chuck completely to ensure proper circulation if applicable 24 Remove all accessories including shaver blades drill bits and saw blades before sterilizing a handpiece NOTE This identifies information that can simplify the setup and operation of this device 1 Read this User s...

Страница 10: ... 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 Temperature Limits for Storage and Transport Alternating Current Pressure Limits for Storage and Transport Fuse Humidity Limits for Storage and Transport Equipotential Equipment Potential Protective Earth Ground Functional...

Страница 11: ...ection USB Universal Serial Bus For use ONLY with thumb drive RS 232 Serial Port Arthrex Integration Catalog number The product meets the essential requirements of Medical Device Directive 93 42 EEC Serial number Non Sterile Quantity Do not use if package is damaged Consult Instructions for Use No user serviceable parts inside Electrical hazard Authorized Representative in the European Community ...

Страница 12: ...s days of receiving the device Refer also to our General Terms of Business The warranty is not valid if modifications are made to the product or repairs are completed outside of Arthrex or an authorized Arthrex distributor Arthrex will answer any questions referring to the quality reliability and or shelf life of any product identified in this User s Guide This is not a warranty document For all w...

Страница 13: ...ntinuous operation The 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 deactivated When the fault is removed and the fuse cools down typically about 30 seconds operation resumes at the pre failure settings The cable and all handpieces can be sterilized so handpieces can be changed during...

Страница 14: ...User s Guide Product Features AR 8305Console Front View Figure 1 shows the front panel of the AR 8305 console Features and symbols are identified in Table 1 below Figure 1 Front Panel of Console Table 1 Front Panel Elements 1 On Off Power Switch 2 Handpiece Connectors 3 Synergy Product Logo 4 Handpiece Symbols 5 Touch Panel Visual Display 6 Footswitch Symbols 7 Footswitch Connectors 8 Arthrex Logo...

Страница 15: ... Equipotential Bonding Symbol 3 Address 4 Fan 5 USB port For use ONLY with thumb drive 6 Serial ports for Arthrex integration 7 Serial number label 8 Model number label 9 Fuse holder for the Power Entry Module 10 Fuse label AR 8305 Display Messages The console s Touch Panel Visual Display TPVD 5 provides information about the status of the AR 8305 settings in real time A list of informational and ...

Страница 16: ...o reset the console FWD or REV ONLY Temporarily displayed for tools that do not support OSC mode HP BUTTON STUCK Remove HP Repower System Either a handpiece button is being pressed or is stuck while connecting to console Communication error results Remove the handpiece and repower the system to reset the console TOGGLE NOT ALLOWED Temporarily displayed when toggle button pressed with tool that doe...

Страница 17: ...ver connected No Footswitch Temporarily displayed when footswitch disconnected Osc1 Current status Motor is oscillating Power Failure Power supply error Rev Current mode Reverse stopped Rev1 Current status Motor is moving in reverse Run1 Current status Motor is running for saw Safe Mode Excessive HP communication errors have occurred Sag Saw Sagittal Saw connected SFS Standard Footswitch Connected...

Страница 18: ...sor 1 0 Stuck Low 1 Stuck High 2 No Errors Found H13 Multiple sensors shorted H14 Multiple sensors stuck high low H15 Invalid Hall sensor states detected C31 Over current 7 5A during retries C32 Over current 5 0A during retries C33 Over 5 0A for 6 seconds C34 Over 7 0A for 3 seconds C35 Over 7 5A for 1 second C36 Over 8 0A for 250ms C37 Over 8 1A in INT0 C38 Over 8 1A in A D ISR C39 Over 8 0A in F...

Страница 19: ...eatures Standard Footswitch AR 8310 Figure 3 shows the Standard Footswitch Features and symbols are identified in Table 5 below Figure 3 Standard Footswitch Description Table 5 Elements of the Standard Footswitch 1 Cable 2 Speed Increase button 3 Toggle button 4 Forward pedal 5 Oscillation pedal 6 Reverse pedal ...

Страница 20: ... Table 7 Standard Footswitch Specifications Functions Reverse Forward Oscillation 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 IP68 Cleaning disinfecting and sterilization Refer to Sections 6 0 Cleaning and Disinfecting and Section 7 0 Sterilization Ambient Conditions for Operation Table 8 AR 8305 Ambient ...

Страница 21: ...n UL 60601 1 2003 Canadian Certification CAN CSA C22 2 No 60601 1 2008 02 EU Certification EN 60601 1 2006 IEC 60601 1 3rd Ed AM1 2012 EMC Certifications CISPR 11 EMC Class Class A CISPR 11 EMC Group Group 1 EMC Certification IEC 60601 1 2 2014 Class A Safety Certification Marking CE Markings MDD Classification CE Marking for MDD93 43 EEC Class IIA MDD Marking Rule 9 For all other accessories refe...

Страница 22: ...your Arthrex representative for further information Avoid positioning the console so that it is difficult to disconnect coupler or plug from supply main NOTE Extension cords must meet the local electrical standard Extension cords are not recommended to be used with the AR 8305 Connecting an extension cord to the AR 8305 may result in a reduced level of safety The console is designed to meet power ...

Страница 23: ...the AC inlet 5 Ensure that fuse holder is fully seated and that the tabs snap back Always use fuses with the correct values to avoid allowing overcurrent to enter the system An incorrect fuse may increase the risk of electrical shock or fire hazard NOTE The AR 8305 console incorporates a universal AC input power supply A voltage selection switch is not required Electromagnetic Compatibility This d...

Страница 24: ...y 3 Power ON the console 4 Allow it to fully initialize 5 Attach the shaver handpiece 6 Attach a footswitch if applicable W A R N I N G DO NOT stack or place equipment adjacent to the AR 8305 console if possible If such a configuration is necessary carefully observe the configuration in question to ensure that the electromagnetic interference does not degrade the performance Do not attach handpiec...

Страница 25: ... the console s handpiece receptacle Align the red dots on the connector and receptacle so they engage easily Setting up Other Accessory Handpieces Only use handpieces and cables that have been developed by Arthrex specifically for the Synergy Resection Other accessory handpieces are available with the Synergy Resection and may require an accessory cable Specific instructions for use of an accessor...

Страница 26: ...isplay Two Tools Attached Table 11 Main Screen Display Elements 1 The main screen divided into two sections when two tools are attached 2 Settings button on the lower right corner in the single screen mode 3 Up button 4 Down button 5 Tool name 6 Footswitch displayed in green if Footswitch Override is disabled SFS Standard Footswitch GFS Gas Footswitch 7 Speed setting 8 Direction or Mode indicator ...

Страница 27: ...nd Down buttons in dual screen mode The tool name is positioned as depicted in the above diagrams Footswitch data is positioned below the tool name The speed setting is displayed in large numeric digits They are visible from a distance by the surgeon in the OR Direction or mode indicators are below the speed setting in large characters They are visible from a distance by the surgeon in the OR Dire...

Страница 28: ...screen section 5 4 below 3 Footswitch Override button When the Footswitch Override button is pressed the software displays the Footswitch Override screen section 5 5 below 4 Reset Defaults button When the Reset Defaults button is pressed the software displays the Reset Defaults screen which asks for confirmation before resetting all settings to the factory defaults section 5 6 below 5 Information ...

Страница 29: ... three navigation buttons Menu Home and Cancel as described in Table 13 below Figure 7 Language Selection Display Operation Table 13 Language Menu Display Operation 1 Select Language radio buttons Select the language of choice 2 Menu button When pressed the software stores the selected language and returns to the Menu screen 3 Home button When pressed the software stores the selected language and ...

Страница 30: ...e Selection Screen Operation Table 14 Oscillation Mode Display Operation 1 Channel 1 The software supports each handpiece channel with its own oscillation mode 2 Channel 2 3 Oscillation Mode radio buttons Select the oscillation mode Standard Efficient or Aggressive 4 Menu button When pressed the software stores the selected mode and returns to the Menu screen 5 Home button When pressed the softwar...

Страница 31: ...h is attached to the console When disabled both buttons on the handpiece and the footswitch will function This screen also includes Menu Home and Cancel buttons as described in Table 15 below Figure 9 Footswitch Override Selection Screen Operation Table 15 Footswitch Override Display Operation 1 2 Channel 1 Channel 2 The software displays the current settings for footswitch override for each chann...

Страница 32: ...s screen is displayed when the Reset Defaults button is pressed on the Settings screen Figure 10 Reset Defaults Screen Operation The software displays two buttons that allows the user to confirm resetting of factory defaults as described in Table 16 below Table 16 Reset Defaults Display Operation 1 Prompt to confirm resetting to factory defaults 2 Yes to reset to factory defaults 3 No to exit with...

Страница 33: ...plays the Model Software Versions and Builds for each controller along with Menu and Home buttons as described in Table 17 below Figure 11 Information Screen Operation Table 17 Information Screen Display Operation 1 Model Software Versions Builds for each controller 2 Menu button Returns to the menu screen 3 Home button Returns to the main screen ...

Страница 34: ... to the system A single handpiece screen is displayed with a single screen while a two handpiece screen has two equally sized sections top and bottom A single handpiece screen has the same content as a dual handpiece screen section with the exception of the OSC Mode button on a single handpiece screen Figure 12 Single Handpiece Screen Oscillation Mode Location Table 18 Oscillation Mode Operation 1...

Страница 35: ... an alternating clockwise counterclockwise direction The duration of each direction is specified in the Shaver Controller SRS document 5 Channel 1 Forward button 6 Channel 2 Forward button When the Forward button is pressed the handpiece motor moves in a clockwise direction when observed from the tip of the shaver 7 Channel 1 Up button 8 Channel 2 Up button When the Up button is pressed the speed ...

Страница 36: ...ings button is displayed between the Up and Down buttons for both sections in a dual screen mode or in the lower right corner in a single screen mode When the Settings button is pressed for 3 seconds the software switches the controller into speed test mode See Speed Test Mode Speed Test Mode The software enters the Speed Test mode when the Menu button is pressed and held for 3 seconds until a tri...

Страница 37: ...It does not cycle through regular increments NOTE While operating handpieces the settings can be changed without risk of damaging the motor or console W A R N I N G Do not have the device in direct contact with patient if high frequency devices are in use or if the patient requires defibrillation Console Speed Controls The Speed Increase and Speed Decrease buttons adjust the speed Each time a butt...

Страница 38: ...ard Any other combination of simultaneous button and pedal activations are ignored by the device This operation applies to both the console front panel buttons and the supported footswitch pedals Cruise Control Use the Gas Pedal Footswitch to engage the cruise control function The Gas Pedal Footswitch is available as an optional system accessory To operate the cruise control you must 5 13 3 1 Crui...

Страница 39: ...he Cruise function 5 13 3 4 Disable Cruise Lock If any other footswitch or console panel button is activated while in the LOCKED state the Cruise function becomes DISARMED with the exception noted in item Remove Foot 5 13 3 5 Disable Cruise Set If the Toggle Cruise Control or Front Panel buttons are pressed at any time after the Cruise Control button is selected i e in the ARMED or LOCKED state th...

Страница 40: ...he toggle button switches to the next oscillation mode in this sequence efficient mode aggressive mode standard mode and then back to efficient mode If two footswitches are installed with only one connected attachment the footswitch without a connected attachment is inactive If the Toggle switch is activated when only one attachment is connected and this attachment does not support oscillation mod...

Страница 41: ...press it again to get the speed setting to cycle to the minimum setting Gas Pedal Footswitch The Forward Reverse and Oscillation pedals linearly adjust the speed When the pedal is pressed it returns an analog signal that is converted to a corresponding RPM between the minimum and maximum speed of the attachment connected to the footswitch Multi Function Footswitches Wireless and Corded Multi Funct...

Страница 42: ...rial compatibility NEVER clean the console with liquid cleaners If there is dust remove it with dry compressed air Do NOT clean the device with abrasive cleaning or disinfectant compounds solvents or other materials that could scratch or damage the device Footswitches The footswitch is provided non sterile and must not be sterilized To clean and disinfect unplug the cord from the console and add t...

Страница 43: ...le surface disinfectant Thoroughly rinse the cable under lukewarm distilled water or preferably demineralized sterile water See Section 7 0 for sterilization information Refer to the Instructions for Use package insert for detailed Adapteur Power System II Accessory Attachments DFU 0149 XX cleaning and sterilization instructions included with each cable Additional copies of this insert can be obta...

Страница 44: ... brush Rinse the handpiece thoroughly after cleaning Disinfect the handpiece with a commercially available disinfectant Thoroughly rinse the handpiece under lukewarm distilled water or preferably demineralized sterile water See Section 7 0 for sterilization information Always comply with the instructions issued by the manufacturer of the disinfectant NEVER place the shaver handpiece in Cidex or ot...

Страница 45: ...x website at www Arthrex com or by contacting your local Arthrex Representative 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 Liquid on the cable connector of the accessory device can damage the device Before connecting the cable ensure the receptacles are clean and dry...

Страница 46: ... disease are believed to be resistant to normal processes of disinfection and sterilization 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...

Страница 47: ...t is the most knowledgeable about the Arthrex Medical Resection Systems and foot pedal and handpiece and will provide competent and efficient service Any services and or repairs done by any unauthorized repair facility may result in reduced performance of the instruments or instrument failure Life Expectancy Life expectancy for the console is approximately 5 years under normal use and standard of ...

Страница 48: ...00 PM CET How to Display the Software Version Technical Support may request the software version of the AR 8305 Follow these instructions to display the software version 1 Power On the AC mains power switch 3 on the AR 8305 2 The software version is displayed on the TPVD during the power up sequence Additional Technical Information Contact your Arthrex representative if require more comprehensive ...

Страница 49: ...ch is functional 7 Handpiece is too hot after sterilization 8 Handpiece over current is detected 9 Defective handpiece 1 Check the connector is plugged into the correct channel receptacle 2 Check both connectors are plugged in properly 3 Dry thoroughly 4 Replace the cable 5 Operate the device using the console unit 6 Replace the handpiece 7 Allow it to cool down as indicated in the WARNING in Sect...

Страница 50: ...nnectors are plugged in properly 2 Check the connector with another handpiece 3 Replace 4 Send in for repairs If the problems persist disinfect the Synergy Resection 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 12 0 for...

Страница 51: ...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...

Страница 52: ...CISPR 11 Group1 AR 8305 Synergy Resection system uses RF energy only for its internal function Therefore its RF emissions are very low and not likely to cause any interference in nearby equipment RF emissions CISPR 11 Class A The AR 8305 Synergy Resection system is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network...

Страница 53: ...e that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 UT 0 0 5 cycle 0 45 90 135 180 225 270 and 3150 UT 0 1 cy...

Страница 54: ...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 tr...

Страница 55: ...low according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 7 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed ab...

Страница 56: ...lvd 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 Printed in USA ...

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