AR-9800 SynergyRF Users Guide Rev 0 Jan 2021

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Table of Contents 1.0 GENERAL WARNINGS, TRAINING AND SAFETY NOTICES READ THIS FIRST ... 6 1.1 1.2 1.3 1.4

Important Safety Conventions ... 6 Symbol Definitions ... 11 Shipping, and Unpacking Information ... 13 Information ... 13

2.0 PRODUCT DESCRIPTION AND INTENDED USE ... 14 2.1

Product Description... 14

2.1.1

2.2

Indications for Use and Contraindications ... 16

Product Features ... 17

2.2.2 2.2.3 2.2.4

AR-9800 Console - Front View... 17 AR-9800 Console - Rear View ... 18 AR-9800 Display Messages ... 19

3.0 TECHNICAL SPECIFICATIONS ... 21 3.1 3.2 3.3 3.4 3.5 3.6

Console... 21 Ambient Conditions for Operation ... 21 Ambient Conditions for Storage (in shipping packaging)... 21 SynergyRF Footswitch... 21 Safety, EMC, and Regulatory Requirements ... 22 Power Curves ... 23

4.0 SETUP ... 29 4.1 4.2 4.3 4.4 4.5 4.6 4.7

How to Set Up the Console ... 29 AC Power Safety Considerations ... 29 Replacing the Fuses ... 30 Electromagnetic Compatibility ... 30 Basic Setup Procedure for the AR-9800 Console ... 31 Setting up a Footswitch ... 32 Setting up the Arthrex Single Use, disposable ApolloRF® device (Probe) ... 32

5.0 OPERATION AND FREQUENTLY USED FUNCTIONS ... 34 5.1 5.2

Main Screen ... 34 Settings Menu Main Screen ... 36

5.2.1 5.2.2

Language Selection Screen ... 38 Information Screen ... 38

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5.2.3 5.2.4 5.2.5

5.3 5.3.1

5.4 5.5 5.6

Reset Defaults Screen... 39 Probe Buttons ... 41 Footswitch Override Screen ... 42

Footswitches ... 44 SynergyRF Footswitch – Ablate Power Change button ... 44

Accessory Arthrex ApolloRF® devices (Probe) ... 45 Normal Operation ... 46 System Shutdown... 46

6.0 CLEANING AND DISINFECTING ... 47 6.1 6.2

Console AR-9800 ... 47 Footswitches ... 47

7.0 STERILIZATION ... 48 7.1

Transmissible Spongiform Encephalopathy Agents ... 48

8.0 MAINTENANCE ... 49 8.1 8.2 8.3

Periodic Maintenance ... 49 Service Manual ... 49 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

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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

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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

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General Warnings, Training and Safety Notices - Read This First RF™ Synergy User’s Guide

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.

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General Warnings, Training and Safety Notices - Read This First RF™ Synergy User’s Guide

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. 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.

W A R N I N G ! 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 DFU-0221-7r0_fmt_en-US Page 6 of 58

General Warnings, Training and Safety Notices - Read This First RF™ Synergy User’s Guide 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.

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General Warnings, Training and Safety Notices - Read This First RF™ Synergy User’s Guide

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 (AR9800) 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. DFU-0221-7r0_fmt_en-US Page 8 of 58

General Warnings, Training and Safety Notices - Read This First RF™ Synergy User’s Guide 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.

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General Warnings, Training and Safety Notices - Read This First RF™ Synergy User’s Guide 7. 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.

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General Warnings, Training and Safety Notices - Read This First RF™ Synergy User’s Guide 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.

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

Safety Sign

2797

The product meets the essential requirements of Medical Device Directive 93/42/EEC

EC REP

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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General Warnings, Training and Safety Notices - Read This First RF™ Synergy User’s Guide

QTY

NON STERILE

REF

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

Non Sterile

SN

[x]

[Arthrex integration]

Serial number

RF probe handpiece

Catalog number

Do not use if package is damaged

Serial port

IP22

International Protection marking

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.

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General Warnings, Training and Safety Notices - Read This First RF™ Synergy User’s Guide 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. Information In CE Accepting Countries: Procedures carried out using these devices may be used on the general population. In CE Accepting Countries: The clinical benefits associated with the use of these devices outweigh the known clinical risks. In CE Accepting Countries: There are no unacceptable residual risks or uncertainties associated with the clinical use of these devices.

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Product Description and Intended Use SynergyRF™ User’s Guide

2.0 Product Description and Intended Use 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)

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Product Description and Intended Use SynergyRF™ User’s Guide Figure 1

Connection Diagram

2

1 5

6

4

7

3

Table 1 1. 2. 3. 4. 5. 6. 7.

Connection Elements

Generator/Console Power Cord Footswitch Footswitch Cable Connector RF Ablation Device (Probe) Probe Cable Connector Suction Tube Connector

Save the packaging for later transport of the device.

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Product Description and Intended Use SynergyRF™ User’s Guide

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.

W A R N I N G ! 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.

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Product Description and Intended Use SynergyRF™ User’s Guide 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

1 2

Front Panel of Console

3

Table 2 1. 2. 3. 4. 5. 6. 7. 8.

4

5

6

7

Front Panel Elements

On / Off Power Switch Power Switch IEC 60417-5010 symbol (On / Off) Footswitch Symbol Footswitch Connector Touch Screen Display Probe Handpiece Symbol Probe Handpiece Connector Type CF Symbols (Electric Shock Protection)

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8

Product Description and Intended Use SynergyRF™ User’s Guide

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. 2. 3. 4. 5. 6. 7. 8. 9. 10.

Supply main input Plug Equipotential Bonding Pin with Stamped Equipotential Bonding Symbol Address label Fan USB port (For use ONLY by service technicians) Serial ports for Arthrex integration (to only be connected to IEC 60601-1 approved equipment) Serial number label Model number label Fuse holder for the Power Entry Module Fuse label

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