Arthrex AR-8305 User manual

Synergy Resection
User’s Guide
The Arthrex Synergy Resection User’s Guide provides safety
operation information for all components of the Arthrex Synergy
Resection console (Model AR-8305), including the accessories. 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-[phone]
www.arthrex.com
Arthrex GmbH
Erwin-Hielscher-Strasse 9
81249 München, Germany
Tel: [phone]
www.arthrex.de
DFU-0213-7 Revision 0 08/2019
© 2019 Arthrex, Inc. All rights reserved.
AR-8305

This page intentionally left blank

DFU-0213-7 Rev. 0 Page i
Table of Content
1.0 GENERAL WARNINGS AND SAFETY NOTICES - READ THIS FIRST ...... 1
1.1 Important Symbols and Conventions................................................................................ 1
1.2 Symbol Definitions............................................................................................................. 4
1.3 Shipping, Unpacking, and Warranty Information.............................................................. 6
2.0 PRODUCT DESCRIPTION .................................................................................. 7
2.1 Product Description and Intended Use ............................................................................. 7
2.2 Product Features ............................................................................................................... 8
2.2.1 AR-8305Console - Front View................................................................................................. 8
2.2.2 AR-8305 Console - Rear View ................................................................................................. 9
2.2.3 AR-8305 Display Messages..................................................................................................... 9
2.3 Applied Parts and Accessory Features ............................................................................ 13
2.3.1 Standard Footswitch (AR-8310)............................................................................................ 13
3.0 TECHNICAL SPECIFICATIONS........................................................................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
4.6 Setting up a Footswitch ................................................................................................... 19
4.7 Setting up the Shaver Handpieces................................................................................... 19
4.8 Setting up Other Accessory Handpieces.......................................................................... 19
4.9 Shutdown Procedure....................................................................................................... 19
5.0 OPERATION AND FREQUENTLY USED FUNCTIONS ...............................20
5.1 Main Screen..................................................................................................................... 20
5.2 Settings Menu Main Screen............................................................................................. 21
5.3 Language Selection Screen .............................................................................................. 23
5.4 Oscillation Mode Selection Screen.................................................................................. 24

DFU-0213-7 Rev. 0 Page ii
5.5 Footswitch Override Screen ............................................................................................ 25
5.6 Reset Defaults Screen...................................................................................................... 26
5.7 Information Screen.......................................................................................................... 27
5.8 Buttons ............................................................................................................................ 28
5.8.1 Buttons - Main Screen .......................................................................................................... 28
5.9 Speed Test Mode............................................................................................................. 30
5.10 Speed Adjustment ........................................................................................................... 30
5.11 Oscillation Mode Adjustment.......................................................................................... 30
5.12 Accessory Handpiece Speed Limits and Deltas ............................................................... 31
5.12.1 Drill Speeds........................................................................................................................... 31
5.12.2 Console Speed Controls........................................................................................................ 31
5.13 Attachment Motor Control.............................................................................................. 32
5.13.1 Definition of Direction .......................................................................................................... 32
5.13.2 Forward, Reverse and Oscillation Modes............................................................................. 32
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) AGENTS 40
9.0 MAINTENANCE...................................................................................................41
9.1 Life Expectancy ................................................................................................................ 41
9.2 Periodic Maintenance...................................................................................................... 41
10.0 TECHNICAL SUPPORT......................................................................................42
10.1 How to Display the Software Version.............................................................................. 42
10.2 Additional Technical Information.................................................................................... 42
11.0 TROUBLESHOOTING........................................................................................43
11.1 Troubleshooting Interference with Other Devices.......................................................... 44

DFU-0213-7 Rev. 0 Page iii
12.0 REPAIR POLICY..................................................................................................45
13.0 END OF LIFE, ENVIRONMENTAL DIRECTIVES .........................................45
14.0 ELECTROMAGNETIC EMISSIONS..................................................................46
List of Figures
Figure 1 Front Panel of Console........................................................................................................8
Figure 2 Rear Panel of Console .........................................................................................................9
Figure 3 Standard Footswitch - Description..................................................................................13
Figure 4 Main Screen Display - 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 Screen Oscillation Mode Location................................................... 28
Figure 13 Two Handpiece Buttons - Operation..............................................................................29

DFU-0213-7 Rev. 0 Page iv
List of Tables
Table 1 Front Panel Elements .......................................................................................................... 8
Table 2 Rear Panel Elements............................................................................................................ 9
Table 3AR-8305 Display Messages ..............................................................................................10
Table 4 *TOOL FAILURE* Error Code Definitions .................................................................... 12
Table 5 Elements of the Standard Footswitch ............................................................................. 13
Table 6 AR-8305 Console Specifications ......................................................................................14
Table 7 Standard Footswitch Specifications ................................................................................14
Table 8 AR-8305 Ambient Conditions for Operation.................................................................14
Table 9 AR-8305 Ambient Conditions for Storage......................................................................14
Table 10 Safety, EMC, and Regulatory Requirements .................................................................15
Table 11 Main Screen Display Elements ........................................................................................20
Table 12 Settings Menu Display - Operation.................................................................................22
Table 13 Language Menu Display - Operation .............................................................................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
Table 23 Troubleshooting: Faults, their Causes and Solutions ................................................... 43
Table 24 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions ................46
Table 25 System Cables ....................................................................................................................46
Table 26 Guidance and Manufacturer's Statement - Electromagnetic Immunity ....................47
Table 27 Guidance and Manufacturer's Statement – Recommend Separation Distance
between portable and mobile RF communications equipment and the
Model AR-8305 ..................................................................................................................49

General Warnings and Safety Notices - Read This First
Synergy Resection User’s Guide
DFU-0213-7 Rev. 0 Page 1 of 50
1.0 General Warnings and Safety Notices - Read This First
Important Symbols and Conventions
It is imperative that the symbols and conventions listed below be clearly
understood. The Synergy Resection User’s Guide identifies critical, important, and
useful information using these symbols and conventions.
Users of this device are encouraged to contact their Arthrex representatives if
they require a more comprehensive surgical technique.
WARNING!
The WARNING! is the most important safety symbol. It identifies critical
information that must be followed precisely to avoid injury or death.
1. Use this device only for purposes described in the User’s Guide, under the
supervision of a trained and licensed physician.
2. No modifications of the console (AR-8305) or accessories are allowed.
3. Use this device 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.
4. Do not open or attempt to service this system, as this may void your
warranty. 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 high-frequency devices are
in use, or if the patient requires defibrillation.
7. 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 electromagnetic interference does not
degrade performance.
8. Use only Arthrex approved accessories. Other accessories may result in
increased emissions or decreased immunity of the system. Contact your
Arthrex representative for a complete list of accessories. DO NOT modify any
accessory. Failure to comply may result in patient and/or operating room staff
injury.
9. This equipment is NOT suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen rich or nitrous oxide environment.
10. Do not have device in direct contact with patient if high-frequency devices are
in use or if the patient requires defibrillation.
11. After autoclaving, the accessory devices are VERY HOT. Handle with care to
avoid burns.

General Warnings and Safety Notices - Read This First
Synergy Resection User’s Guide
DFU-0213-7 Rev. 0 Page 2 of 50
The PRECAUTION! symbol identifies methods and procedures
that must be followed to avoid damaging the device or causing it
to malfunction.
1. DO NOT – under any condition or for any reason – open the console (AR-
8305) or any other shaver accessory.
2. Only use replacement power cords that meet medical grade standards
according to IEC 60320-1, Detachable Power Supply Cords or electrical
standards for the designated country where the AR-8305 is being used.
Contact your Arthrex representative for further information.
3. Avoid position console so that it is difficult to disconnect coupler or plug from
supply main.
4. Connecting an extension cord to the AR-8305 may result in a reduced level of
safety.
5. Always use fuses with the correct values to avoid allowing overcurrent to
enter the system.
6. An incorrect fuse may increase the risk of electrical shock or fire hazard.
7. This device has passed testing for EMI / RFI radiation and susceptibility and
EMC compatibility. This device may cause interference to other devices in the
near vicinity if not set up and used as Arthrex instructs.
8. Do not attach handpieces or footswitches during the Self Test or the
Programming 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 console to prevent accidental separation during use. To avoid
damage, disconnect the footswitch by pulling on the cable connector shell
(plug) only.
12. The accessory handpiece cable connects and locks to the console to prevent
accidental separation during use. To avoid damage, disconnect the
footswitch by pulling on the cable connector shell (plug) only.
13. Always comply with the instructions issued by the manufacturer of the
cleaning disinfectant regarding concentration, exposure times,
temperature and material compatibility.
14. NEVER clean the console with liquid cleaners. If there is dust, remove it with
dry compressed air.
15. Do NOT clean the device with abrasive cleaning or disinfectant
compounds, solvents, or other materials that could scratch or damage
the device.
16. The footswitch is NOT suitable to be cleaned and disinfected in a
thermo washer disinfector.
17. NEVER allow the console receptacles to have any contact with liquids. If
there is dust or moisture on the receptacles, remove it with dry compressed
air. ONLY dry connectors should be plugged into the console.

General Warnings and Safety Notices - Read This First
Synergy Resection User’s Guide
DFU-0213-7 Rev. 0 Page 3 of 50
18. Refer to the Instructions for Use package insert for detailed shaver handpiece
(DFU-0154-XX) and Adapteur Power System II Accessory Attachments
(DFU- 0149-XX) cleaning and sterilization instructions included with each
handpiece. Additional copies of this insert can be obtained from the Arthrex
website at www.arthrex.com, or by contacting your local Arthrex
representative.
19. NEVER place the shaver handpiece in Cidex or other aldehyde disinfectant
solutions.
20. 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.
21. Liquid on the cable connector of the accessory device can damage the
device. Before connecting the cable, ensure the 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 Guide thoroughly before operating the device and save it for
future reference.
2. Extension cords must meet local electrical standard. Extension cords are not
recommended to be used with the AR-8305.
3. The AR-8305 console incorporates a universal AC input power supply. A
voltage selection switch is not required.
4. AR-8305 has been designed to accept EMC from other devices within the
limitations as described in section 14.0.
5. The setup for a footswitch is the same for all models. The console detects
which version is attached and allows the appropriate functions.
6. While operating the handpieces, the settings can be changed without risk of
damaging the motor or console.

General Warnings and Safety Notices - Read This First
Synergy Resection User’s Guide
DFU-0213-7 Rev. 0 Page 4 of 50
Symbol Definitions
Safety Sign
Follow Operating
Instructions
Caution: Federal Law
Restricts this device to
sale by or on the order
of a Physician.
On / Off (push-push)
Type BF Equipment
Precaution of Warning
Notice
Fragile
Keep Dry This Side Up
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]
WEEE [Waste
Electronics and
Electrical Equipment]
Symbol. Regarding
European Union End-
of-Life of Product.
RF Symbol. Non-
ionizing
Electromagnetic
Radiation