Arthrex Synergy AR-9800 User manual

SynergyRF™
AR-9800
User’s Guide
The Arthrex SynergyRF™ User’s Guide provides safety operation
information for all components of the Arthrex SynergyRF™ console
(Model AR-9800), including accessories. All operating personnel
must read this User’s Guide thoroughly prior to using this system
and follow all safety warnings, cautions, and notes.
Arthrex, Inc.
1370 Creekside Blvd.
Naples, FL 34108-1945 USA
Toll Free: 1-[phone]
www.arthrex.com
Arthrex GmbH
Erwin-Hielscher-Strasse 9
81249 München, Germany
Tel: [phone]
Fax: [phone]
www.arthrex.de
DFU-0221-6 Revision 0 08/2020
© 2020 Arthrex, Inc. All rights reserved.

This page intentionally left blank

DFU-0221-6r0_fmt_en-US
Page 1 of 62
Table of Contents
1.0 GENERAL WARNINGS, TRAINING AND SAFETY NOTICES -
READ THIS FIRST...................................................................................................... 6
1.1 Important Safety Conventions............................................................................................. 6
1.2Symbol Definitions............................................................................................................. 11
1.3 Shipping, and Unpacking Information ............................................................................... 13
1.4 Information ........................................................................................................................ 13
2.0 PRODUCT DESCRIPTION AND INTENDED USE .......................................14
2.1 Product Description ........................................................................................................... 14
2.1.1 Indications for Use and Contraindications .............................................................................. 16
2.2 Product Features................................................................................................................ 17
2.2.2 AR-9800 Console - Front View................................................................................................. 17
2.2.3 AR-9800 Console - Rear View.................................................................................................. 18
2.2.4 AR-9800 Display Messages...................................................................................................... 19
3.0TECHNICAL SPECIFICATIONS .......................................................................21
3.1 Console............................................................................................................................... 21
3.2 Ambient Conditions for Operation .................................................................................... 21
3.3 Ambient Conditions for Storage (in shipping packaging) .................................................. 21
3.4 SynergyRF Footswitch ......................................................................................................... 21
3.5 Safety, EMC, and Regulatory Requirements...................................................................... 22
3.6 Power Curves ..................................................................................................................... 23
4.0 SETUP ...................................................................................................................29
4.1 How to Set Up the Console................................................................................................ 29
4.2 AC Power Safety Considerations........................................................................................ 29
4.3 Replacing the Fuses............................................................................................................ 30
4.4 Electromagnetic Compatibility .......................................................................................... 30
4.5 Basic Setup Procedure for the AR-9800 Console............................................................... 31
4.6 Setting up a Footswitch ..................................................................................................... 32
4.7 Setting up the Arthrex Single Use, disposable ApolloRF® device (Probe)........................... 32
5.0 OPERATION AND FREQUENTLY USED FUNCTIONS...............................34
5.1 Main Screen ....................................................................................................................... 34
5.2 Settings Menu Main Screen............................................................................................... 36
5.2.1 Language Selection Screen...................................................................................................... 38
5.2.2 Information Screen.................................................................................................................. 38

DFU-0221-6r0_fmt_en-US
Page 2 of 62
5.2.3 Reset Defaults Screen.............................................................................................................. 39
5.2.4 Probe Buttons.......................................................................................................................... 41
5.2.5 Footswitch Override Screen .................................................................................................... 42
5.3 Footswitches ...................................................................................................................... 44
5.3.1 SynergyRF Footswitch – Ablate Power Change button.................................................... 44
5.4 Accessory Arthrex ApolloRF® devices (Probe)..................................................................... 45
5.5 Normal Operation.............................................................................................................. 46
5.6 System Shutdown .............................................................................................................. 46
6.0 CLEANING AND DISINFECTING ....................................................................47
6.1 Console AR-9800................................................................................................................ 47
6.2 Footswitches ...................................................................................................................... 47
7.0 STERILIZATION.................................................................................................48
7.1 Transmissible Spongiform Encephalopathy Agents .......................................................... 48
8.0 MAINTENANCE ..................................................................................................49
8.1 Periodic Maintenance........................................................................................................ 49
8.2 Service Manual................................................................................................................... 49
8.3 Annual Calibration ............................................................................................................. 49
9.0 TECHNICAL SUPPORT .....................................................................................50
9.1 How to Display the Software Version................................................................................ 50
10.0 TROUBLESHOOTING ....................................................................................51
10.1 Troubleshooting Interference with Other Devices............................................................ 51
11.0 REPAIR POLICY..............................................................................................52
12.0 END OF LIFE, ENVIRONMENTAL DIRECTIVES......................................52
13.0 ELECTROMAGNETIC EMISSIONS ..............................................................53

DFU-0221-6r0_fmt_en-US
Page 3 of 62
List of Figures
Figure 1 Connection Diagram............................................................................................................ 15
Figure 2 Front Panel of Console ........................................................................................................ 17
Figure 3 Rear Panel of Console.......................................................................................................... 18
Figure 4 Error Screen Display............................................................................................................ 20
Figure 5 Main Screen Display............................................................................................................ 34
Figure 6 Settings Menu Display - Operation ................................................................................... 36
Figure 7 Language Selection Display - Operation ..........................................................................38
Figure 8 Information Screen - Operation .........................................................................................39
Figure 9 Reset Defaults Screen - Operation .....................................................................................40
Figure 10 Power Change Button Screen – Operation ...................................................................41
Figure 11 Footswitch Override Selection Screen - Operation......................................................43
Figure 12 SynergyRF Footswitch - Description............................................................................... 44
Figure 13 ApolloRF®probe - Description.........................................................................................45

DFU-0221-6r0_fmt_en-US
Page 4 of 62
List of Tables
Table 1 Connection Elements........................................................................................................... 15
Table 2 Front Panel Elements........................................................................................................... 17
Table 3 Rear Panel Elements ............................................................................................................18
Table 4 AR-9800 Display Messages................................................................................................. 19
Table 5 Error Screen Display – Descriptions.................................................................................. 20
Table 6 AR-9800 Console Specifications.........................................................................................21
Table 7 AR-9800 Ambient Conditions for Operation ...................................................................21
Table 8 AR-9800 Ambient Conditions for Storage ........................................................................21
Table 9 Synergy Footswitch Specifications .................................................................................... 21
Table 10 Safety, EMC, and Regulatory Requirements.................................................................... 22
Table 11 Main Screen Display Elements........................................................................................... 34
Table 12 Settings Menu Display - Operation ................................................................................... 36
Table 13 Language Menu Display - Operation................................................................................ 38
Table 14 Information Screen Display - Operation...........................................................................39
Table 15 Reset Defaults Display - Operation ...................................................................................40
Table 16 Probe Buttons Display - Operation.................................................................................... 41
Table 17 Footswitch Override Display - Operation ........................................................................43
Table 18 Elements of the SynergyRF Footswitch ..............................................................................44
Table 19 ApolloRF®probe - Description.............................................................................................45
Table 20 Troubleshooting: Faults, their Causes and Solutions...................................................... 51
Table 21 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions...................53
Table 22 System Cables....................................................................................................................... 53
Table 23 Guidance and Manufacturer's Statement - Electromagnetic Immunity.......................54
Table 24 Guidance and Manufacturer's Statement – Recommend Separation ...........................57

General Warnings, Training and Safety Notices - Read
This First
SynergyRF™ User’s Guide
DFU-0221-6r0_fmt_en-US
Page 5 of 58
This is not a warranty document. For all warranty information, including disclaimers, exclusions,
terms, conditions and related provisions, refer to the "Arthrex U.S. Product Warranty" section of the
Arthrex, Inc. website, found at www.arthrex.com whose provisions are incorporated herein by
reference.

General Warnings, Training and Safety Notices - Read
This First
SynergyRF™ User’s Guide
DFU-0221-6r0_fmt_en-US
Page 6 of 58
1.0 General Warnings, Training and Safety Notices - Read
This First
It is imperative that the symbols and conventions listed below be clearly understood.
The SynergyRF User’s Guide identifies critical, important, and useful information using
these symbols and conventions.
1.1 Important Safety Conventions
Warnings and safety conventions follow IEC 60601-1 and IEC 60601-2-2.
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. Caution: Federal law restricts this device to sale by or on the order of a
physician.
2. This device is intended to be used by a trained medical professional.
3. Failure to follow the set up instructions and/or continuing to use the console
(AR-9800) without resolving an alarm could result in a serious patient
adverse event.
4. Failure to adhere to the set up instructions and use of Arthrex certified
devices may result in inaccurate sensing and feedback by the device. It is
imperative that the user is aware of the potential compromise in patient
safety when an alarm on the console is ignored or silenced incorrectly.
NEVER ignore or silence alarms. Follow appropriate troubleshooting
procedures and carefully monitor the patient. Only Arthrex certified devices
must be used.
5. This device is only for use in normal arthroscopic procedures as described in
the User’s Guide, under the supervision of a trained and licensed physician.
This device should not be used by untrained personnel or used for
indications other than those described in this User’s Guide.
6. No modification of the console (AR-9800) or accessories are allowed.
7. DO NOT open or attempt to service this system, as this may void your
warranty. There are no user-serviceable parts inside. Removing the

General Warnings, Training and Safety Notices - Read
This First
SynergyRF™ User’s Guide
DFU-0221-6r0_fmt_en-US
Page 7 of 58
cover may introduce an electric shock hazard by exposing you to
dangerously high voltages or other risks. If the system malfunctions,
return it for service immediately.
8. To avoid the RISK of electric shock, this equipment must only be connected
to a SUPPLY MAIN with Protective Earth Terminal.
9. DO NOT stack or place equipment adjacent to the AR-9800 console, if
possible. If such a configuration is necessary, carefully observe the
configuration in question to ensure that electromagnetic interference does not
degrade performance.
10. 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.
11. DO NOT use in the presence of flammable anesthetics or oxidizing gases
such as nitrous oxide, oxygen, or endogenous gases. All oxygen connections
must be leak free for the duration of the surgical procedure.
12. Do not have the device in direct contact with the patient, if the patient
requires defibrillation.
13. The safety and effectiveness of the AR-9800 is verified and documented;
however, the AR-9800 must be used with an awareness of the risk of damage
to surrounding tissue through iatrogenic injury.
14. Always start with the lowest possible power setting to achieve the desired
effect.
15. Small electric arcs between the active electrode and tissue being resected can
produce low-frequency current that may produce local neuromuscular
stimulation. Per standard of care, ensure that the patient’s arms and/or legs
are supported appropriately.
16. Biohazard waste, such as explanted devices, needles and contaminated
surgical equipment, should be safely disposed of in accordance with the
institutions policy.
17. Serious incidents should be reported to Arthrex Inc., or an in-country
representative, and to the health authority where the incident occurred.

General Warnings, Training and Safety Notices - Read
This First
SynergyRF™ User’s Guide
DFU-0221-6r0_fmt_en-US
Page 8 of 58
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-
9800) or any other accessory.
2. DO NOT disconnect the foot pedal unit from the console by pulling on the
cable. Retract the connector tab and gently pull on the body of the connector
to remove the cable from the console.
3. Only use replacement power cords that meet medical grade standards
according to IEC 60320-1 Subclause 3.21, Detachable Power Supply Cords or
electrical standards for the designated country where the AR-9800 is being
used. Contact your Arthrex representative for further information.
4. Avoid positioning the console so that it is difficult to disconnect coupler or
plug from supply main.
5. To prevent electrical shock, do not use extension cords or 2 to 3 pronged
adaptors.
6. Always use fuses with the correct values to avoid allowing overcurrent to
enter the system.
7. An incorrect fuse may increase the risk of electrical shock or fire hazard.
8. 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.
9. Do not attach compatible disposable devices or footswitches during the Self
Test or the Programming Modes.
10. Do not detach a disposable device or footswitch from the console while the
disposable device or footswitch is activated. The disposable device will stop
functioning if this is attempted.
11. Only use footswitches developed by Arthrex specifically for the AR-9800
SynergyRF console.
12. Only use disposable devices developed by Arthrex specifically for the
SynergyRF console.
13. The footswitch cable connects and locks to the console to prevent accidental
separation during use. To avoid damage, always disconnect the footswitch
by pulling on the cable connector shell (plug) only.
14. The accessory device cable connects to the console. To avoid damage, always
disconnect the accessory device by pulling on the cable connector shell (plug)
only.
15. Always comply with the instructions issued by the manufacturer of the
disinfectant.
16. NEVER use liquid to clean the accessory device connector contacts. Remove
dust regularly with dry compressed air.

General Warnings, Training and Safety Notices - Read
This First
SynergyRF™ User’s Guide
DFU-0221-6r0_fmt_en-US
Page 9 of 58
17. Do NOT clean the device with abrasive cleaning or disinfectant compounds,
solvents, or other materials that could scratch or damage the device
18. NEVER allow the console receptacles to have any contact with liquids. If
there is dust or moisture on the receptacles, remove with dry compressed air.
ONLY dry connectors should be plugged into the console.
19. Liquid on the cable connector of the accessory device can damage the device.
Before connecting the cable, ensure the receptacles are clean and dry.
20. For aspirating Probes/disposable devices ALWAYS attach the suction tube
connector to an adequate suction source. ALWAYS ensure the suction
control valve on the device is open to ensure proper circulation of fluid.
21. Refer to the Instructions for Use package insert ApolloRF®disposable devices
(DFU-0242-XX) for detailed device cleaning and sterilization instructions
included with each device Additional copies of this insert can be obtained
from the Arthrex website at www.arthrex.com, or by contacting your local
Arthrex Representative.
NOTE: This identifies information and training that can simplify the setup
and operation of this device.
1. The user should be experienced in arthroscopic surgical techniques before using the
Arthrex SynergyRF System.
2. Read this User’s Guide thoroughly before operating the device, and save it for future
reference. For additional information and training, contact your local Arthrex
representative.
3. If required by local regulations, connect the console to the hospital equalization
connector with an equipotential cable. Connect the power cord to a wall outlet
having the correct voltage. Otherwise, product damage may result.
(The equipotential connector provided complies with IEC 60601-1:2005/A1:2012. The proper
use of equipotential cables and equipotential earthing systems must be governed by local
hospital and regulatory requirements)
4. The AR-9800 console incorporates a universal AC input power supply. A voltage
selection switch is not required.
5. AR-9800 has been designed to accept EMC from other devices within the limitations
as described in section 13.0.
6. Setup for a footswitch is the same for all models. The console detects which version is
attached and allows appropriate functions.
7. Surgeons are advised to review the product specific surgical technique prior to
performing any surgery. Arthrex provides detailed surgical techniques in print,

General Warnings, Training and Safety Notices - Read
This First
SynergyRF™ User’s Guide
DFU-0221-6r0_fmt_en-US
Page 10 of 58
video, and electronic formats. The Arthrex website also provides detailed surgical
technique information and demonstrations. Or, contact your Arthrex representative
for an onsite demonstration.

General Warnings, Training and Safety Notices - Read
This First
SynergyRF™ User’s Guide
DFU-0221-6r0_fmt_en-US
Page 11 of 58
1.2 Symbol Definitions
All of the symbols used on the labeling along with the title, description and standard
designation number may be found on our website at www.arthrex.com/symbolsglossary.
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 CF Equipment
The product meets the
essential requirements
of Medical Device
Directive 93/42/EEC
Authorized
representative in the
European Community
Precaution of Warning
Notice
Fragile, handle with care
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

General Warnings, Training and Safety Notices - Read
This First
SynergyRF™ User’s Guide
DFU-0221-6r0_fmt_en-US
Page 12 of 58
Equipotential
[equipment potential]
Protective earth terminal
Manufacturer
Date of manufacture;
year and month.
Electrical Waste
RF symbol. Non-ionizing
electromagnetic
radiation
Quantity Footswitch connection
Universal Serial Bus
[For use ONLY with
thumb drive]
10101 Serial port
[Arthrex integration]
Non Sterile SN Serial number
Catalog number
RF probe handpiece
Do not use if package
is damaged IP22
International Protection
marking
[x] Square brackets that enclose a letter, number or lower-case
Roman numeral reference a callout on a line drawing. Section 2.2.,
Product Features, includes line drawings of products associated
with the AR-9800. Each line drawing has its own callout system to
identify important elements of each product.

General Warnings, Training and Safety Notices - Read
This First
SynergyRF™ User’s Guide
DFU-0221-6r0_fmt_en-US
Page 13 of 58
1.3 Shipping, and Unpacking Information
Carefully unpack and inspect all components for shipping
damage. Do not use the disposable Arthrex ApolloRF®Device
(Probe) if packaging is damaged and sterile barrier has been
compromised.
Any damage could compromise patient safety and should be reported
immediately to Arthrex or any authorized Arthrex distributor. The warranty
could be voided if shipping or first-installation damage is not reported within
seven (7) business 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.
1.4 Information
In EU Only: Procedures carried out using these devices may be used on the
general population.
In EU Only: The clinical benefits associated with the use of these devices
outweigh the known clinical risks.
In EU Only: There are no unacceptable residual risks or uncertainties associated
with the clinical use of these devices.

Product Description and Intended Use
SynergyRF™ User’s Guide
DFU-0221-6r0_fmt_en-US
Page 14 of 58
2.0 Product Description and Intended Use
2.1 Product Description
The Arthrex SynergyRF Generator is classified as a FDA Class II medical device.
The Arthrex SynergyRF Generator is an advanced electrosurgical generator
utilizing feedback from the surgical site such as, voltage, current and power. It is
designed to meet the needs of arthroscopic surgical procedures. The generator
has an advanced output control algorithm using feedback systems that are
capable of adjusting the output as the tissue characteristics change. This will
result in a more consistent clinical effect at the surgical site.
The Supply Main is applied to the console from a detachable power cord.
The console is activated by a footswitch and/or hand switch.
The front panel display is a touch screen, back lit LCD display that is used to
select between ABLATE and COAG (coagulation) and provides a means for
power adjustment, mode information, and warning/caution indicators of the
generator status.
The AR-9800 SynergyRF Generator contains hardware for disposable device
recognition.
The AR-9800 SynergyRF Generator, Applied Parts and Accessories:
•AR-9800 SynergyRF Generator
•Power Cord
•User’s Guide
•Accessory RF Devices (Probe, supplied separately)
•SynergyRF Footswitch (supplied separately)

Product Description and Intended Use
SynergyRF™ User’s Guide
DFU-0221-6r0_fmt_en-US
Page 15 of 58
Figure 1 Connection Diagram
Table 1 Connection Elements
1.
Generator/Console
2.
Power Cord
3.
Footswitch
4.
Footswitch Cable Connector
5.
RF Ablation Device (Probe)
6.
Probe Cable Connector
7.
Suction Tube Connector
Save the packaging for later transport of the device.
4
1
2
3
5
6
7

Product Description and Intended Use
SynergyRF™ User’s Guide
DFU-0221-6r0_fmt_en-US
Page 16 of 58
2.1.1 Indications for Use and Contraindications
Indications for Use
The Arthrex SynergyRF System, when used with an ApolloRF®Ablation Device
(Probe), is intended for use as a complete system in the resection, ablation, and
coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and
orthopedic procedures. Specifically, the ablation devices, electrosurgical
generator and their accessories are used for arthroscopic surgery of the shoulder,
wrist, hand, elbow, hip, knee, foot and ankle.
Contraindications
The Arthrex SynergyRF System is contraindicated in any procedure where a
conductive solution is not used. The System is also contraindicated for patients
who have cardiac pacemakers or other electronic implants without specific
instructions from the manufacturer of the pacemaker or implant. Please refer to
the RF Probe Instructions for Use for a comprehensive list of contraindications
regarding specific procedures. The generator is not intended to be used with a
neutral electrode.
WARNING!
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 and RF Ablation Probe
Instructions for Use.

Product Description and Intended Use
SynergyRF™ User’s Guide
DFU-0221-6r0_fmt_en-US
Page 17 of 58
2.2 Product Features
2.2.2 AR-9800 Console - Front View
Figure 2 shows the front panel of the AR-9800 console. The features and symbols
are identified in Table 2 below.
Figure 2 Front Panel of Console
Table 2 Front Panel Elements
1.
On / Off Power Switch
2.
Power Switch IEC 60417-5010 symbol (On / Off)
3.
Footswitch Symbol
4.
Footswitch Connector
5.
Touch Screen Display
6.
Probe Handpiece Symbol
7.
Probe Handpiece Connector
8.
Type CF Symbols (Electric Shock Protection)
1
2
4
7
6
5
3
8

Product Description and Intended Use
SynergyRF™ User’s Guide
DFU-0221-6r0_fmt_en-US
Page 18 of 58
2.2.3 AR-9800 Console - Rear View
Figure 3 shows the rear panel of the console. The features and symbols are
identified in Table 3 below.
Figure 3 Rear Panel of Console
Table 3 Rear Panel Elements
1.
Supply main input Plug
2.
Equipotential Bonding Pin with Stamped Equipotential Bonding Symbol
3.
Address label
4.
Fan
5.
USB port (For use ONLY by service technicians)
6.
Serial ports for Arthrex integration (to only be connected to IEC 60601-1
approved equipment)
7.
Serial number label
8.
Model number label
9.
Fuse holder for the Power Entry Module
10.
Fuse label