Reusable Nitinol RF Electrode Instructions for Use Rev B March 2021

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. ™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third-party trademark, which is property of its respective owner. Pat. http://www.abbott.com/patents © 2021 Abbott. All Rights Reserved.

Indications for Use Abbott Medical radiofrequency (RF) electrodes are intended for use in the lesioning of peripheral nerve tissue.

Warnings 

Do not use in the central nervous system.

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Must be manually cleaned and sterilized before first and every use.

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It is important that the instructions for use, supplied with the generator, be read and understood before each use.

Connections This RF electrode is designed for use with an Abbott Medical RF lesion generator. After connecting and before each use, ensure that there is a temperature reading between 35°C and 38°C (body temperature) on the lesion generator temperature indicator.

Disposable Cannula This RF electrode has been designed to be used with an Abbott Medical RF disposable cannula. Ensure that the correct length of disposable cannula is used.

RF Electrode Tip Position The tip of the RF electrode, when in the cannula, should be visible to the eye within the non-insulated tip of the cannula. This should always be checked with each cannula prior to use. WARNING: Always remove the electrode before positioning, repositioning, or removing a cannula. Failure to comply may cause damage to the electrode.

Expected Service Life The expected service life of the RF electrode is defined as 90 days or 25 cleaning and sterilization cycles, whichever comes first. The number and date of uses can be documented in the tracking card packaged with the device. The service life is influenced to a considerable degree by careful handling.

Handling Handle the electrode diligently and carefully, and use unconditional observance of these instructions for use to ensure the RF electrode performs as intended throughout the expected service life. Poor handling may seriously affect the normal characteristics and technical factors of the electrode.

Manual Cleaning Procedure (Before Sterilization) NOTE: Keep the electrode moist after use to facilitate cleaning. CAUTION: Operatives should wear appropriate levels of protective clothing. CAUTION: The effectiveness of the subsequent cleaning process depends on the removal of gross soil. Decontamination may be impaired by dried or coagulated tissue. Therefore, particular attention should be paid to removing all debris by following the recommended procedure.

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1.

Remove the protection tube then rinse the RF electrode with running tap water at 30-40°C (86-104°F) to remove visible soil until visibly clean.

2.

Prepare an enzymatic cleaner such as Prolystica 2 x concentrate enzymatic per manufacturer's recommendations. Immerse the RF electrode in the blood-dissolving enzymatic solution, taking care not to immerse the connector end as damage to the product may occur. Allow them to soak for a minimum of 30 minutes. CAUTION: If the connector is inadvertently immersed, allow the solution to drain out of the connector by inverting it for a minimum of 30 minutes prior to sterilization.

3.

Thoroughly clean, rinse and remove gross matter; i.e., blood, mucous, tissue from the product until visually clean, using a disposable clean soft non-linting cloth moistened with prepared blood dissolving enzymatic cleaning solution and a sterile brush with rigid nylon bristles and/or a sterile syringe. Thoroughly pay particular attention to areas, like crevices, lumens, and other hard to reach places where soil may be shielded. Use a sterile pipe cleaner to thoroughly brush all crevices and lumen.

4.

Using a disposable clean soft non-linting cloth, moistened with prepared blood dissolving enzymatic cleaning solution, wipe the cable and connector thoroughly until the device is visually clean paying particular attention to areas, like crevices, lumens, and other hard to reach places where soil may be shielded.

5.

Using ambient temperature filtered RO / DI water, rinse the product until there are no visible signs of the cleaning solution remaining. Dry the devices with a clean soft non-linting cloth. Filtered pressurized air may be used to aid drying (<40 psi).

6.

Visually inspect the product for any remaining soil and repeat the above steps if necessary.

Use of Ultrasonic Cleaners Do not use ultrasonic cleaners as damage to the product may occur and reduce the useful life of the product.

Sterilization Caution (Before Sterilization) Before sterilization, remove and dispose of any protection tube and inspect the RF electrode, cable, and connector for any signs of damage or corrosion. Do not use if any damage or corrosion is observed. Caution (After Sterilization) After sterilization and before each therapy, plug the RF electrode into the lesion generator and ensure the readings of temperature are between 35°C and 38°C (body temperature) and valid impedance range based on generator model. Do not use if any of the readings are not within the specified ranges. If the generator does not display a correct body temperature or impedance reading, discontinue use of the RF electrode and dispose of appropriately.

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Steam Sterilization (Moist Heat) Procedure CAUTION: Ensure that the cable does not contact the metal housing of the autoclave or other metal instruments during the cycle, as this may reduce the effective life of the product. NOTE: The following steam sterilization autoclave cycles have been validated for the sterilization of Abbott Medical reusable nitinol RF electrodes.

Wrapped (Porous Load) Kimgaurd 600 (1-ply polypropylene) wrap to be used or a similar FDA cleared wrap/pouch Pre-vacuum air removal sterilizer Temperature: 132°C (270°F) Exposure time: 4 minutes Gravity displacement sterilizer Temperature: 132°C (270°F) Exposure time: 15 minutes

Drying Procedure Following 132°C (270°F) steam sterilization cycle for 4 minutes or 15 minutes Minimum drying time: 30 minutes After drying, allow the electrode to cool down to room temperature before renewed use.

General Notes 

It is advised that sterilization equipment should have validation certification and performance qualification test undertaken of their process cycles for effective processing.

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Healthcare facilities should validate the process they use employing the actual equipment, wrapping methods, and operators that routinely process these products.

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Products are free of latex.

Symbols The following symbols may be found on the product or product label: Symbol

Definition Caution, consult accompanying documents Consult instructions for use Catalog number Serial number Unique Device Identification Manufacturer Date of manufacture Distributed by

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Symbol

Definition Temperature limitations Prescription use only Do not use if package is damaged Contents quantity Non-sterile

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Minta Medical Ltd Caddick Road Knowsley Business Park Knowsley, Prescot Merseyside L34 9HP UK +44 0 151 548 6818

2021-03 ARTEN600162737 B

*600162737*

Abbott Medical 5050 Nathan Lane North Plymouth, MN 55442 USA +1 855 478 5833 +1 651 756 5833