COOLIEF MULTI-COOLED RF Nitinol Probe and Connector Cable Instructions for Use

Protective Tube Handle

RF Electrode RF Probe Plug-In

Fig. 1

Bend Relief PMP-YYC-N

RF Generator Plug-In

RF Probe Cable

RF Probe Connector

RF Generator Connector Cable PMX-BAY-BAY

Fig. 2

RF Generator Plug-In

RF Probe Connector

RF Generator Connector Cable Fig. 3

PMX-RAD-BAY

RF Generator Plug-In

RF Probe Connector

RF Generator Connector Cable Fig. 4

PMX-BAY-ORA

RF Generator Plug-In

RF Probe Connector

RF Generator Connector Cable PMX-NEU-BAY

Fig. 5

RF Generator Cable Plug-In

RF Generator Connector Cable PMX-SAC-BAY

Fig. 6

NON STERILE

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Non-Pyrogenic

RF Probe Connector

Rx Only

Caution

Consult instructions for use

Dispose of properly

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HALYARD* Radiofrequency Nitinol Probe & Radiofrequency Generator Connector Cable

Rx Only: Federal (U.S.A) law restricts this device to sale by or on the order of a physician.

Device Description

The HALYARD* Radiofrequency (RF) Nitinol Probes (Fig. 1) are individual electrodes that are used with a disposable radiofrequency (RF) cannula (sold separately) of varying gauge and corresponding length. The HALYARD* Radiofrequency (RF) Generator Connector Cables [PMX-BAY-BAY (Fig.2), PMX-RAD-BAY (Fig. 3), PMX-BAY-ORA (Fig. 4), PMX-NEU-BAY (Fig. 5) and PMX-SAC-BAY (Fig. 6)] respectively connect the HALYARD* RF Nitinol Probes to the RF Generator, connect the HALYARD* RF Nitinol Probes to the Valleylab® RFG Series Generator, connect the HALYARD* RF Nitinol Probes to the Neurotherm® Generator or connect the HALYARD* RF Generator or Kimberly-Clark® Radiofrequency Generator (formerly Baylis Pain Management Generator) to the Smith & Nephew® Probe Model: 4-Pin Intradiscal Catheter, 4-Pin Intradiscal Catheter XL or 4-Pin Intradiscal Decompression Catheter.

Indications For Use

• The RF Generator is capable of delivering significant electrical power. Patient or operator injury can result from improper handling of the RF Probe, particularly when operating the device. • There is a rare potential for localized skin burn if RF lesion site has insufficient subcutaneous tissue (<15 mm) or is near a shallow metal implant. • During power delivery, the patient should not be allowed to come in contact with grounded metal surfaces. • Do not remove or withdraw the device while energy is being delivered. • There is a rare potential for localized skin burn if RF lesion site has insufficient subcutaneous tissue (<15 mm) or is near a shallow metal implant.

Precautions •

HALYARD* Radiofrequency Nitinol Probe and HALYARD* Radiofrequency Generator Connector Cable will be used in conjunction with a radiofrequency generator to create lesions in nervous tissue.

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Contraindications

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For patients with cardiac pacemakers, a variety of changes can occur during and after the treatment. In sensing mode the pacemaker may interpret the RF signal as a heartbeat and may fail to pace the heart. Contact the pacemaker company to determine if the pacemaker should be converted to fixed-rate pacing during the RF procedure. Evaluate the patient’s pacing system after the procedure. Check the compatibility and safety of combinations of other physiological monitoring and electrical apparatus to be used on the patient in addition to the RF lesion generator. If the patient has a spinal cord, deep brain, or other stimulator, contact the manufacturer to determine if the stimulator needs to be in the bipolar stimulation mode or in the OFF position. This procedure should be reconsidered in patients with any prior neurological deficit. The use of general anesthesia is contraindicated. To allow for patient feedback and response during the procedure, treatment should be performed under local anesthesia. Systemic infection or local infection in area of the procedure. Blood coagulation disorders or anticoagulant use.

Warnings

• The HALYARD* RF Nitinol Probes and RF Generator Connector Cables are shipped nonsterile and must be cleaned and sterilized prior to use as instructed in the Instructions for Use. • The HALYARD* RF Nitinol Probes and RF Generator Connector Cables are reusable devices. Failure to properly clean and sterilize the device can cause patient injury and/or the communication of infectious diseases from one patient to another. • The HALYARD* RF Nitinol Probes and RF Generator Connector Cables must be used with the correct connector cable. Attempts to use it with other RF Generator Connector Cables can result in electrocution of the patient or operator. • Laboratory staff and patients can undergo significant x-ray exposure during RF procedures due to the continuous use of fluoroscopic imaging. This exposure can result in acute radiation injury as well as increased risk for somatic and genetic effects. Therefore, adequate measures must be taken to minimize this exposure. • Discontinue use if inaccurate, erratic or sluggish temperature readings are observed. Use of damaged equipment may cause patient injury. • Do not modify HALYARD* Equipment. Any modifications may compromise the safety and efficacy of the device. • When an RF Generator is activated, the conducted and radiated electrical fields may interfere with other electrical medical equipment.

• •

Do not attempt to use the HALYARD* RF Nitinol Probes and RF Generator Connector Cables before thoroughly reading the Instructions for Use and the User’s Manual for the RF Generator. The HALYARD* RF Nitinol Probes and RF Generator Connector Cables should be used by physicians familiar with RF lesion techniques. Apparent low power output or failure of the equipment to function properly at normal settings may indicate: 1) faulty application of the dispersive electrode or 2) power failure to an electrical lead. Do not adjust treatment parameters before checking for obvious defects or misapplication. In order to prevent the risk of ignition make sure that flammable material is not present in the room during RF power application. It is the physician’s responsibility to determine, assess and communicate to each individual patient all foreseeable risks of the RF lesion procedure.

Adverse Events Potential complications associated with the use of this device include but are not limited to: infection, bleeding, nerve damage, visceral injury, increased pain, failure of technique, paralysis and death.

Product Specifications The HALYARD* RF Nitinol Probes should be used by physicians familiar with RF lesion techniques.

HALYARD* Nitinol RF Probe (Fig. 1) The HALYARD* RF Nitinol Probes (PMP) are individual electrodes that are used with disposable RF cannula (sold separately) of varying gauge and corresponding length. • Available with straight and curved cannulae (16-22 gauge). • Model number indicates cannula information. Model Number PMP-YYC-N, where: YY: indicates length of cannula associated with the probe C: if present, indicates that cannula is curved. Note: Please contact Halyard Health for a list of all model numbers and sizes. • RF Nitinol Probes are shipped nonsterile and must be sterilized as per Instructions for Use prior to use. • Are supplied non-pyrogenic. • Are supplied with the following additional parts: • protective tubing, to prevent bending or kinking of the RF Electrode during handling. • Black 4-pin, male connector (Probe Plug-In) to connect the HALYARD* RF Nitinol Probe to the RF Generator Connector Cable. • Black probe cable for use with straight cannula and a white probe cable for use with curved cannula. Storage Instructions • •

HALYARD* RF Nitinol Probes should be stored in a cool, dry place. Store the RF Nitinol Probes in the Sterilization and Storage Tray provided to reduce the risk of damage due to storage.

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Special Handling Instructions

Inspection Prior to Use

The HALYARD* RF Nitinol Probe is delicate due to its small diameter RF electrode. Do not bend, kink, or stress the RF electrode. Do not crush or splice the probe cable. Doing so could damage the temperature sensing mechanism in the device and lead to improper temperature measurement.

Perform the following checks before the patient is presented for the procedure. These steps will allow you to verify that the equipment you will use is in proper working order. Do these tests in a sterile environment. • Sterility Check: The HALYARD* RF Nitinol Probes and RF Generator Connector Cables are shipped nonsterile. They must be sterilized prior to each use. • Visual Inspection: Ensure RF Nitinol Probes and RF Generator Connector Cables have no visible damage such as discoloration, cracks, label fading, cable splice, or kinks. Do NOT use damaged or defective equipment. • Residual Moisture: Ensure the RF Nitinol Probes and RF Generator Connector Cables are dry. Residual moisture can cause malfunctions.

HALYARD* RF Generator Connector Cables • •

Five models (PMX-BAY-BAY, PMX-RAD-BAY, PMX-BAY-ORA, PMX-NEU-BAY, PMX-SAC-BAY) Shipped nonsterile and must be sterilized as per User’s Manual prior to first use.

PMX-BAY-BAY (Fig. 2) The HALYARD* PMX-BAY-BAY connects the HALYARD* RF Nitinol Probe to the Generator (PMG). • Two different connectors: 1. 4-pin female – RF Probe Connector (to connect to Probe) 2. 14-pin male – RF Generator Plug-In (to connect to Generator)

PMX-RAD-BAY (Fig. 3) The HALYARD* PMX-RAD-BAY connects the HALYARD* RF Nitinol Probe (PMP-N) to a Valleylab® RFG Series Generator. • Two different connectors: 1. 4-pin female – RF Probe Connector (to connect to Probe) 2. 14-pin male – RF Generator Plug-In (to connect to Generator)

PMX-BAY-ORA (Fig. 4) The HALYARD* PMX-BAY-ORA connects the HALYARD* RF Generator to the Smith & Nephew Probe Model: 4-Pin Intradiscal Catheter or 4-Pin Intradiscal Catheter XL. • Two different connectors: 1. 4-pin female – RF Probe Connector (to connect to Probe) 2. 14-pin male – RF Generator Plug-In (to connect to Generator) Note: Cable should NOT be used with the Intradiscal decompression catheter if the generator in use is Generator Version 1.2 or lower. Note: If using the PMG Version 2.0, ensure that the secondary thermocouple option is disabled. Refer to Generator-TD User Manual. • Are used to connect an IDL probe (model 902002) to the HALYARD* RF Generator. • Should NOT be used with the IDL decompression catheter if the generator in use is PMG Version 1.2 or lower. • Have two different connectors: 1. 4-pin female – RF Probe Connector (to connect to Probe) 2. 14-pin male – RF Generator Plug-In (to connect to Generator)

PMX-NEU-BAY (Fig. 5) The HALYARD* PMX-NEU-BAY connects the HALYARD* RF Nitinol Probes to the Neurotherm® Generator. • Two different connectors: 1. 4-pin female – RF Probe Connector (to connect to Probe) 2. 4-pin male (metal) – RF Generator Plug-In (to connect to Generator)

PMX-SAC-BAY (Fig. 6) The HALYARD* PMX-SAC-BAY connects the HALYARD* Nitinol RF Probe to the STRYKER® RF Generator or STRYKER® RF Multi-Gen. • Two different connectors: 1. 4-pin female - RF Probe Connector (to connect to Probe) 2. 12-pin male (metal) - RF Generator Plug-In (to connect to Generator cable)

Storage Instructions • •

HALYARD* RF Generator Connector Cables should be stored in a cool, dry place. Store the RF Generator Connector Cables in the Sterilization and Storage Tray provided to reduce the risk of damage due to storage.

Autoclave Case is • • • • 4

Shipped nonsterile. Should be used at all times to store the HALYARD* RF Nitinol Probe and HALYARD* RF Generator Connector Cable. Steam sterilizable and should be used to hold the devices while they are being sterilized. NOT to be used with STERRAD®.

Equipment Required RF lesion procedures should be performed in a specialized clinical setting with fluoroscopic equipment. The RF equipment required for the procedure is as follows: • Disposable RF Cannula • RF Nitinol Probe and corresponding RF Generator Connector Cable • RF Generator • Disposable Indifferent (dispersive) Patch (DIP) electrode meeting ANSI/AAMI standard HF-18 requirements for electrosurgical electrodes.

Instructions for Use 1. Assemble all required equipment for the intended procedure and position the patient as necessary. 2. Attach the Disposable Indifferent (dispersive) Patch (DIP) electrode. Read and follow the manufacturer’s Instructions for Use of the (DIP) electrode to determine proper placement. Always use DIP electrodes that meet or exceed ANSI/AAMI HF-18 requirements. 3. Connect the appropriate connector cable to the connector cable connection on the RF generator. Maintain access to the RF Nitinol Probe Connector on the connector cable in order to facilitate easy attachment of the probe. 4. With the stylet in the cannula, insert the cannula into the patient using fluoroscopic guidance to place the active tip at the desired lesion location. 5. Once the cannula is properly placed, carefully remove the stylet from the cannula and insert the (pre-sized) RF Electrode down the shaft of the cannula. 6. Attach the probe to the connector cable (via the Probe Plug-In and RF Nitinol Probe Connector). 7. Stimulate and lesion as necessary. Refer to the RF Generator User’s Manual for more information.

After the Procedure 1. Remove RF electrode of the probe from the cannula. 2. Remove cannula from the patient. 3. Disconnect the RF Nitinol Probe from the RF Generator Connector Cable by pulling on the plug body. Caution: Prevent damage to your cable and probe. When pulling the connectors apart be sure to pull on the plug and not the cable. 4. Disconnect the RF Generator Connector Cable from the generator. 5. Discard the cannula. 6. Remove Disposable Indifferent (dispersive) Patch (DIP) electrode from patient and discard. 7. Prepare the reusable probe and connector cable for cleaning and sterilization. Transfer the used HALYARD* RF Nitinol Probe and HALYARD* RF Generator Connector Cable to a carrying surface and cover them with a wet cloth to ensure that blood and other contaminants do not dry on the surface.

Cleaning and Sterilization Instructions Danger The HALYARD* RF Nitinol Probe and HALYARD* RF Generator Connector Cable are shipped nonsterile and must be cleaned and sterilized as per these Instructions for Use prior to each use. Failure to properly clean and sterilize the device can cause patient injury and/or the communication of infectious diseases from one patient to another.

Important The manufacturer recommends the user follow a quality control program for each sterilization cycle that meets or exceeds American Operating Room Nurses (AORN) Standards, Recommended Practices & Guidelines - 2000. This program includes, but is not limited to recording: • Type of sterilizer and cycle used • Lot control number • Load contents • Exposure time and temperature, if not provided by a recording chart • Operator’s name • Results of sterilization process monitoring (i.e., chemical, mechanical, biological)

Cleaning and Decontamination 1. Ensure that blood and other contaminants do not dry on the HALYARD* RF Nitinol Probe and the HALYARD* RF Generator Connector Cable. 2. Remove the protective tube from the probe and follow the Instructions below for each piece separately. 3. Rinse all parts with deionized water until colorless run-off water occurs. Once the water runs clear soak the parts (except for the connectors) in deionized water at 22°C-48°C for 1 minute. Remove the probe and components from the water and scrub them with a soft bristle brush until they are visually clean. Note: Do not let the connectors soak. Wipe connectors as necessary until they are visually clean. 4. Soak the probe and components (except connectors) in an enzymatic cleaning solution for 20 minutes. Ensure that the temperature of the solution is below 55°C. Scrub again with a soft bristle brush, and rinse thoroughly using deionized water until all traces of detergent residue are removed. 5. Visually inspect the parts again for debris, if any is present repeat steps 3 and 4. 6. Dry the surface of the device on the outside with a clean, dry towel. Put the protective tube back onto the probe and place all parts back in the Sterilization and Storage Tray.

Warning Halyard Health has validated ONLY the previously mentioned cleaning and sterilization methods for the HALYARD* RF Nitinol Probe and HALYARD* RF Generator Connector Cable. No other cleaning and sterilization methods have been tested. If any other type of cleaning or sterilization method is used on these products, it is up to the user to verify sterility. Failure to properly clean the device can lead to patient injury.

Troubleshooting The following table is provided to assist the user in diagnosing potential problems. PROBLEM

COMMENTS

TROUBLESHOOTING

No temperature measurement in treatment mode OR Inaccurate, erratic or sluggish temperature reading in treatment mode

In order to measure temperature the entire system must be connected and all devices must be in good working order.

Ensure that all connections are made: • probe to connector cable • connector cable to generator • generator to power outlet Check for an error message on the generator. Visually inspect the probe or cable for damage. Ensure that devices are dry and at room temperature. If problem persists, discontinue use.

RF Nitinol Probe does not fit into the RF Cannula

The fit of the probe in the cannula is very precise. In very rare situations the manufacturing of the probe and/or cannula may prohibit the correct fit.

Ensure that the stylet has been removed from the cannula. Ensure that the RF Electrode is completely smooth and clean. Check the length of the cannula and ensure that the correctly sized probe is in use. Try another cannula of the same size.

RF Nitinol Probe Connector does not fit in RF Probe Plug-In

Each of the connectors is designed to connect in a specific way for safety reasons. If the connector “keys” are out of line the connectors won’t fit together.

Check that the connector’s keys are lined up in the proper orientation. Ensure that the connectors are clean and unobstructed.

RF Electrode Breaks or Kinks

Due to the small diameter shaft, the RF Electrode portion of the HALYARD* RF Nitinol Probe can withstand very little damage due to handling.

Discard Immediately.

Sterilization (All EXCEPT PMX-SAC-BAY) The following sterilization methods have been validated for use with HALYARD* RF Probes and RF Generator Connector Cables: • Steam Sterilization • Gravity Displacement Steam Sterilization • STERRAD® Sterilization

Sterilization (PMX-SAC-BAY) The following sterilization methods have been validated for use with HALYARD* PMX-SAC-BAY Generator Connector Cable: • Steam Sterilization • Gravity Displacement Steam Sterilization

Steam Sterilization Prevaccum: Wrapped: 132°C-135°C (270°F-275°F) for 3-4 min. Unwrapped: “flash” 132°C for 4 min.

Gravity Displacement Steam Sterilization Wrapped: 132°C- 135°C (270°F - 275°F) for 15 minutes Unwrapped: “Flash” 132°C- 135°C for 15 minutes

STERRAD® Sterilization HALYARD* RF Probes and RF Generator Connector Cables may be sterilized with the following STERRAD® systems: • STERRAD® 100S • STERRAD 50 • STERRAD 200 • STERRAD NX® • STERRAD 100NX All instructions given in the corresponding STERRAD® Sterilization System User’s Guide must be followed. Note: The HALYARD* RF Probe and RF Generator Connector Cable should NOT be sterilized within the autoclave case. Any validated tray recommended for use with STERRAD® may be used. Note: For effective sterilization, the protective tube MUST be removed during sterilization and placed next to the probe in the tray.

Customer Service and Product Return Information If you have any problems with or questions about this HALYARD* Equipment, contact our technical support personnel: Halyard Health 5405 Windward Parkway Alpharetta, GA 30004 USA E-mail: [email protected] 1-844-425-9273 (1-844-HALYARD)

Notes In order to return products under limited warranty you must have a return authorization number before shipping the products back to Halyard Health.

Limited Warranties Halyard Health warrants that these products are free from defects in original workmanship and materials. If these products prove to be defective in original workmanship or original materials, Halyard Health, in its absolute and sole discretion, will replace or repair any such product, less charges for transportation and labor costs incidental to inspection, removal or restocking of product. 5

This limited warranty applies only to original factory delivered products that have been used for their normal and intended uses. Halyard Health’s limited warranty shall NOT apply to Halyard Health’s products which have been repaired, altered or modified in any way and shall NOT apply to Halyard Health’s products which have been improperly stored or improperly installed, operated or maintained contrary to Halyard Health’s Instructions. The warranty period for HALYARD* RF Nitinol Probe and RF Generator Connector Cables is 90 days from the date of purchase, unless otherwise stated.

Disclaimer and Exclusion of Other Warranties There are no warranties of any kind, which extend beyond the description of the warranties above. Halyard Health disclaims and excludes all warranties, whether expressed or implied, of merchantability or fitness for a particular use of purpose.

Limitation of Liability for Damages In any claim or lawsuit for damages arising from alleged breach of warranty, breach of contract, negligence, product liability or any other legal or equitable theory, the buyer specifically agrees that Halyard Health shall not be liable for damages for loss of profits or claims of buyer’s customers for any such damages. Halyard Health’s sole liability for damages shall be limited to the cost to buyer of the specified goods sold by Halyard Health to buyer which give rise to the claim for liability. The buyer’s use of this product shall be deemed acceptance of the terms and conditions of these limited warranties, exclusions, disclaimers and limitations of liability for money damages.

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Distributed in the U.S. by Halyard Health Global Sales, LLC, Roswell, GA 30076 USA In USA, please call 1-800-KCHELPS • www.kchealthcare.com Distributed in the USA by Halyard Sales, LLC, Alpharetta, GA 30004; In USA, please call 1-844-425-9273 • halyardhealth.com Halyard Health, 1400 Holcomb Bridge Rd., Roswell, GA 30076 USA Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004 USA Halyard Health N.V., Da Vincilaan 1, 1935 Zaventem, Belgium Halyard Belgium BVBA, Leonardo Da Vincilaan 1, 1930 Zaventem, Belgium Sponsored in Australia by Halyard Australia Pty Limited; 52 Alfred Street, Milsons Point, NSW 2061 Registered or Trademark ofンク Halyard Health Worldwide, Inc. © 2007 KCWW. All rights reserved. *製造販売元 Trademark ハリヤード・ ヘルスケア ・イ 横浜市西区みなとみら い二丁目2番1号 STERRAD®, Valleylab®, Neurotherm® and Smith Nephew® are trademarks or registered trademarks of their respective or Trademark of Halyard Health,&Inc., or its affiliates. © 2015 HYH. All rights reserved. *Registered Trademark owners. STRYKER®, Valleylab®, Neurotherm® and Smith & Nephew® are trademarks or registered trademarks STERRAD®, 2014-07-31 14-60-650-0-01 / 70164643 of their respective owners. Kimberly-Clark is a Registered Trademark of Kimberly-Clark Worldwide, Inc. 2015-11-30 15-H1-375-0-00 / 70169389 0086