Arthrex SynergyRF AR-9800 User manual

SynergyRF™System
AR-9800
Service Guide
The Arthrex SynergyRF™ System Service Guide provides safety
operation information for all components of the Arthrex SynergyRF
console (Model AR-9800), including accessories. All operating
personnel must read the User’s Guide (DFU-0221-XX) 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-0276-4 Revision 0 2/2020
© 2020 Arthrex, Inc. All rights reserved.

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Table of Contents
1.0 GENERAL WARNINGS, TRAINING AND SAFETY NOTICES -
READ THIS FIRST...................................................................................................... 1
1.1 Important Safety Conventions............................................................................................. 1
1.2 Information .......................................................................................................................... 4
1.3 Symbol Definitions............................................................................................................... 5
2.0 PRODUCT DRAWINGS AND REFERENCES ................................................... 7
2.1 Product Description ............................................................................................................. 7
2.2 Connection Diagram ............................................................................................................ 8
2.3 Product Layout..................................................................................................................... 9
2.3.1 AR-9800 Console - Front View .............................................................................................9
2.3.2 AR-9800 Console - Rear View.............................................................................................10
2.3.3 AR-9800 Display Messages ................................................................................................. 11
2.4 Applied Parts and Accessory Features............................................................................... 13
2.4.1 SynergyRF Footswitch (AR-9800-F).....................................................................................13
2.4.2 ApolloRF®probe..................................................................................................................... 14
2.4.3 ApolloRF Service probe.........................................................................................................15
3.0 TECHNICAL SPECIFICATIONS........................................................................17
3.1 Console............................................................................................................................... 17
3.2 Ambient Conditions for Operation .................................................................................... 17
3.3 Ambient Conditions for Storage (in shipping packaging) .................................................. 17
3.4 SynergyRF Footswitch ......................................................................................................... 17
3.5 Safety, EMC, and Regulatory Requirements...................................................................... 18
3.6 Power Curves ..................................................................................................................... 19
4.0 SETUP....................................................................................................................25
4.1 How to Set Up the Console................................................................................................ 25
4.2 AC Power Safety Considerations........................................................................................ 25
4.3 Replacing the Fuses............................................................................................................ 26
4.4 Electromagnetic Compatibility .......................................................................................... 26
4.5 Basic Setup Procedure for the AR-9800 Console............................................................... 27
4.6 Setting up a Footswitch ..................................................................................................... 28
4.7 Setting up the Arthrex Single Use, disposable ApolloRF device (Probe) ............................ 28

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5.0 MAINTENANCE...................................................................................................30
5.1 Periodic Maintenance........................................................................................................ 30
5.2 User’s Manual (DFU-0221-XX) ........................................................................................... 30
6.0 TECHNICAL SUPPORT......................................................................................31
6.1 How to Display the Software Version................................................................................ 31
7.0 REPAIR POLICY..................................................................................................31
8.0 TROUBLESHOOTING........................................................................................32
8.1 Troubleshooting Interference with Other Devices............................................................ 32
9.0 END OF LIFE, ENVIRONMENTAL DIRECTIVES .........................................33
10.0 ELECTROMAGNETIC EMISSIONS..................................................................34
11.0 BASIC SYSTEM COMMUNICATION PLAN ...................................................40
12.0 PREVENTATIVE MAINTENANCE DOCUMENT (OPTIONAL).................41

Page iv
List of Figures
Figure 1 Connection Diagram.............................................................................................................. 8
Figure 2 Front Panel of Console ..........................................................................................................9
Figure 3 Rear Panel of Console..........................................................................................................10
Figure 4 Error Screen Display............................................................................................................ 12
Figure 5 Standard Footswitch - Description ....................................................................................13
Figure 6 Standard ApolloRF probe - Description ............................................................................. 14
Figure 7 ApolloRF Service probe - Description................................................................................. 15

Page v
List of Tables
Table 1 Connection Elements.............................................................................................................8
Table 2 Front Panel Elements.............................................................................................................9
Table 3 Rear Panel Elements ............................................................................................................10
Table 4 AR-9800 Display Messages................................................................................................. 11
Table 5 Error Screen Display Descriptions.................................................................................... 12
Table 6 Elements of the SynergyRF Footswitch ..............................................................................13
Table 7 ApolloRF probe - Description ..............................................................................................14
Table 8 ApolloRF Service probe - Description................................................................................. 15
Table 9 AR-9800 Console Specifications.........................................................................................17
Table 10 AR-9800 Ambient Conditions for Operation ...................................................................17
Table 11 AR-9800 Ambient Conditions for Storage........................................................................ 17
Table 12 Synergy Footswitch Specifications .................................................................................... 17
Table 13 Safety, EMC, and Regulatory Requirements....................................................................18
Table 14 Troubleshooting: Faults, their Causes and Solutions......................................................32
Table 15 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions................... 34
Table 16 System Cables.......................................................................................................................34
Table 17 Guidance and Manufacturer's Statement - Electromagnetic Immunity....................... 35
Table 18 Guidance and Manufacturer's Statement – Recommend Separation ........................... 39
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
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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 Service 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 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
cover may introduce an electric shock hazard by exposing you to

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dangerous 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.
The PRECAUTION! symbol identifies methods and procedures that
must be followed to avoid damaging the device or causing it to
malfunction.

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1. DO NOT – under any condition or for any reason – open the console (AR-
9800) or any other accessory.
2. 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.
3. Avoid positioning the console so that it is difficult to disconnect coupler or
plug from supply main.
4. To prevent electrical shock, do not use extension cords or 2 to 3 pronged
adaptors.
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 compatible disposable devices or footswitches during Self Test
or the Programming Modes.
9. 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.
10. Only use footswitches developed by Arthrex specifically for the AR-9800
SynergyRF console.
11. Only use disposable devices developed by Arthrex specifically for the
SynergyRF console.
12. 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.
13. 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.
14. Always comply with the instructions issued by the manufacturer of the
disinfectant.
15. NEVER use liquid to clean the accessory device connector contacts. Remove
dust regularly with dry compressed air.
16. Do NOT clean the device with abrasive cleaning or disinfectant compounds,
solvents, or other materials that could scratch or damage the device
17. 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.
18. Liquid on the cable connector of the accessory device can damage the device.
Before connecting the cable, ensure the receptacles are clean and dry.

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19. 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. 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)
2. The AR-9800 console incorporates a universal AC input power supply. A voltage
selection switch is not required.
3. AR-9800 has been designed to maintain safe operation when subjected to
Electromagnetic Interference from other devices within the limitations as described in
section 10.
4. Setup for a footswitch is the same for all models. The console detects which version is
attached and allows appropriate functions.
5. Surgeons are advised to review the product specific surgical technique prior to
performing any surgery. Arthrex provides detailed surgical techniques in print,
video, and electronic formats. The Arthrex website also provides detailed surgical
technique information and demonstrations. Or, contact your Arthrex representative
for an onsite demonstration.
1.2 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.

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1.3 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 Applied Part
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

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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 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 2.3.,
Product Layout 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.

Product Drawings and References
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2.0 Product Drawings and References
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 Mains power supply 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
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 (DFU-0221-XX)
•Accessory RF Devices (Applied part Probe, Service Probe, supplied
separately)
•SynergyRF Footswitch (supplied separately)

Product Drawings and References
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2.2 Connection Diagram
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
4
1
2
3
5
6
7

Product Drawings and References
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2.3 Product Layout
2.3.1 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.
Handpiece Symbol
7.
Handpiece Connector
8.
Type CF Applied Part Symbol (Cardiac Floating)
1
2
4
7
6
5
3
8

Product Drawings and References
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2.3.2 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

Product Drawings and References
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2.3.3 AR-9800 Display Messages
The console's Touch Screen Display [Table 2, item 5] provides information about
the status of the AR-9800 settings in real time. A list of informational and error
messages is shown in Table 4 below. Messages shaded in gray denote that
Arthrex technical support should be contacted for further instructions. Error
display messages reported to Arthrex technical services should include the Error
Message and Error Code for reference (See Figure 4, Error display).
Table 4 AR-9800 Display Messages
Message
Explanation
"Ablation Footswitch Stuck"
A button on the foot switch is stuck. Replace
the foot switch.
"COAG Footswitch Stuck"
A button on the foot switch is stuck. Replace
the foot switch.
"PROBE Already Used"
The RF device attached to the console has
either been previously used, or has been
disconnected and reconnected. Replace with a
new device.
"PROBE Communication Failure"
Communication with the RF device has been
lost. Check the connection and replace the
device, if necessary.
"Replace Probe"
The RF disposable device attached to the
console is malfunctioning.
"System Temperature Failure"
The console temperature is outside of normal
parameters, contact Arthrex technical support.
"Turn off and let cool down"
The console has overheated. Power off the
console for 10 minutes.
"WRAP Footswitch Stuck".
A button on the foot switch is stuck. Replace
the foot switch.
"Contact Technical Services"
Contact Arthrex technical services.
"Configuration File Corruption"
Contact Arthrex technical services.
"Critical Failure"
A terminal fault has occurred, contact Arthrex
technical services.
"LCD File Version Failure"
Touch panel failure, contact Arthrex technical
services.
"LCD Communications Failure"
Touch panel failure, contact Arthrex technical
services
"Main Calibration Required"
Contact Arthrex technical services.
"Power Supply Calibration
Required"
Power supply self-check failure, contact Arthrex
Technical Services.
"Power Supply Failure"
Power supply self-check failure, contact Arthrex

Product Drawings and References
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Message
Explanation
technical services.
"Power Supply POST Failure"
Power supply self-check failure, contact Arthrex
technical services.
"Power Supply PFC Voltage"
Power supply self-check failure, contact Arthrex
technical services.
"Power Supply Excessive Voltage"
Power supply is exceeding the voltage
parameters, contact Arthrex technical services.
"Power Supply Excessive Power"
Power supply is exceeding the power
parameters, contact Arthrex technical services.
"Relay Failure"
Power supply self-check failure, contact Arthrex
technical services.
"RF Output Failure"
Power supply self-check failure, contact Arthrex
technical services.
"Touchscreen Circuit Failure"
Touch panel failure, contact Arthrex technical
services.
Figure 4 Error Screen Display
Table 5 Error Screen Display Descriptions
1.
Error Message
The description of the error/fault experienced
in the system
2.
Error Code
The Error Code specifies which error occurred
for additional reference for Arthrex technical
services
3.
Explanation
Provides context of the error/fault
1
2
3

Product Drawings and References
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2.4 Applied Parts and Accessory Features
2.4.1 SynergyRF Footswitch (AR-9800-F)
Figure 5 shows the SynergyRF Footswitch. The features and symbols are identified in Table 6
below.
Figure 5 Standard Footswitch - Description
2
Table 6 Elements of the SynergyRF Footswitch
1.
Ablation button
2.
Ablate power change button
3.
Coag (coagulate) button
1 3

Product Drawings and References
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2.4.2 ApolloRF®probe
Figure 6 Standard ApolloRF probe - Description
Table 7 ApolloRF probe - Description
1.
Ablate Power Change
button
Each time the button is pressed, the Ablation
setting increases by 1 unit. Activation increases
ablation in a positive direction only. When the
device is at maximum power setting, the user can
return to the minimum setting by pressing the
Ablate Power Change
button one more time.
2.
Ablate button
Activates ablation at the tip of the Apollo
RF
probe.
3.
Coagulation button
Activates coagulation at the tip of the Apollo
RF
probe.
The standard ApolloRF probes are utilized in conjunction with the SynergyRF system 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.
1
2
3