COOLIEF COOLED Radiofrequency Peristaltic Pump Unit Instructions for Use Dec 2015

Front View

Rear View

Burette Holder

Pumphead with Cover

Pump Connector Cable Connection HALYARD* COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit

Fig. 1

COOLIEF* Pump Connector Cable

COOLIEF* Generator

COOLIEF* Pump Unit COOLIEF* TRANSDISCAL* Probe

Tube Kit

COOLIEF* TRANSDISCAL* Introducer

COOLIEF* TRANSDISCAL* Y-Connector Cable

COOLIEF* TRANSDISCAL* Introducer Tube Kit COOLIEF* TRANSDISCAL* Probe HALYARD* COOLIEF* Cooled Radiofrequency System Schematic - Bipolar

Fig. 2

COOLIEF* Pump Connector Cable COOLIEF*Cooled Radiofrequency Stylet COOLIEF* Generator

COOLIEF* Peristaltic Pump Unit Tube Kit

COOLIEF*Cooled Radiofrequency Probe

COOLIEF* Cooled Radiofrequency Connector Cable

COOLIEF*Cooled Radiofrequency Introducer

Grounding Pad

Fig. 3

HALYARD* COOLIEF* Cooled Radiofrequency System Schematic - Monopolar

Rx Only 2

Caution

Consult instructions for use

Warning: Dangerous Voltage

Dispose of properly

HALYARD*

e COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit Rx Only: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

Device Description

The HALYARD COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit (Fig. 1) circulates sterile water through the closed-loop system (including HALYARD* TRANSDISCAL* System, SINERGY* System and other cooled radio-frequency (RF) systems) during pain management RF lesioning procedures. The Pump Unit is to be used in conjunction with a HALYARD COOLIEF* Cooled Radiofrequency Generator or Kimberly-Clark® Cooled Radiofrequency Generator (PMG-115-TD/ PMG-230-TD/PMG-ADVANCED) (formerly Baylis Pain Management Generator), various cooled RF probes and accessories. The HALYARD COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit is controlled by the RF Generator through a connection at the rear of the pump. The HALYARD COOLIEF* Cooled Radiofrequency Peristaltic Pump Connector Cable is used to transfer control signals from the RF Generator to the Pump Unit.

Indications for Use The HALYARD* COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit is to be used in conjunction with a COOLIEF* Cooled RF Generator and with the COOLIEF* TRANSDISCAL* Cooled Radiofrequency Kit for coagulation and decompression of disc material for symptomatic patients with contained herniated discs. It is also to be used with the COOLIEF* SINERGY* Cooled Radiofrequency Kit and other cooled RF probes to create RF lesions in nervous tissue including use in the sacral region. HALYARD* COOLIEF* Cooled Radiofrequency Peristaltic Pump Unit is used for closed-loop circulation of sterile water through the system during RF lesioning procedures.

Contraindications The Pump Unit should be used as stated in the Indications for Use and only with COOLIEF* Cooled Radiofrequency Sterile Tube Kits. 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 a fixed-rate pacing during the radiofrequency 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 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, it should be performed under local anesthesia. Systemic infection or local infection in area of the procedure. Blood coagulation disorders or anticoagulant use.

Warnings

Ensure the RF Generator is OFF before connecting the Pump Unit. Failure to do so could result in damage to the RF Generator. Do NOT service the Pump Unit. If servicing is required, please contact technical support. Do NOT place the Pump Unit on top of the RF Generator or in an area with inadequate ventilation. Do NOT modify the HALYARD* COOLIEF* Equipment. Any modifications may compromise the safety and efficacy of the device. Do NOT use in the presence of flammable anesthetics.

Do not unplug the Pump Unit during RF energy application.

Adverse Events Complications with the use of this device are those associated with the procedures that utilize a RF Probe.

Inspection Prior to Use Prior to use the following inspections should be completed: 1. Inspect the Pump Unit for damage. 2. Inspect the Pump Unit to see that all labels are present and legible.

Equipment Required The Pump Unit is for use in RF pain management procedures performed in specialized clinical settings. The equipment required for the Cooled Radiofrequency procedure are as follows: • COOLIEF* Cooled Radiofrequency Peristaltic Pump Connector Cable • COOLIEF* Cooled Radiofrequency Sterile Tube Kit(s) • COOLIEF* Cooled Radiofrequency Probe(s) • COOLIEF* Cooled Radiofrequency Introducer(s) • COOLIEF* Cooled Radiofrequency Y-Connector Cable (for bipolar procedure) • Dispersive Electrode • Radiofrequency Generator (PMG-115-TD/PMG-230-TD/PMG-ADVANCED)

Instructions for Use (Fig. 2 and 3) 1. Plug the male end of the Connector Cable (TDX-PMG-PPU) into the back of the RF Generator. Ensure the RF Generator is OFF before connecting the Pump Unit. Failure to do so could result in damage to the RF Generator. Plug the female end into the back of the Pump Unit. Screw down both of the connections completely to ensure that the cable does not become disconnected during use. The connection on the RF Generator and the Pump Unit is labeled with the icon below.

2. The pump should be placed on a flat surface. 3. Set up the rest of the system as per the TRANSDISCAL*/SINERGY*/Cooled RF Kit Instructions for Use. Note: The Pump Unit will be controlled by the RF Generator during treatment. The user is not required to activate the pump.

Cleaning and Sterilization Instructions The Pump Unit and Connector Cable are non-body contact devices and therefore are NOT sterile and cannot be sterilized. If cleaning is necessary, the surface of the Pump and/or Connector Cable can be cleaned with a damp lint-free cloth with non-abrasive detergent dissolved in water. Dry the surface after wiping down. NEVER immerse the Pump Unit in water.

Troubleshooting PROBLEM

TROUBLESHOOTING

The pump is not working when in TRANSDISCAL* Disc Biacuplasty Treatment Mode

• Immediately stop the procedure. • Check to ensure that the Pump Unit is connected to the RF Generator. • Check if the pump lids are completely closed. • Check for debris in the pumphead.

The pump will not accept the Tube Kit tubing

Fully open the cover for the pump and place the tubing coming from the bottom of the burette of the Tube Kit into the L-shaped tube guides.

Precautions Do not use the Pump Unit before thoroughly reading the Pump Unit, Tube Kit, TRANSDISCAL*/SINERGY* or any other cooled RF probe and RF Generator Instructions for Use and User’s Manual. Before RF procedures, ensure that the tubing of the Tube Kit has been properly placed in the Pump Unit. Ensure that the pump has completely stopped before inserting or removing tubing from the Pump Unit. 3

PROBLEM

TROUBLESHOOTING

Fluid is not circulating during TRANSDISCAL* Disc Biacuplasty Treatment Mode

• Immediately stop treatment. • Check to see that the tubing is properly placed in the L-shaped tubing guides of the Pump Unit. • Check to see that burette reservoir has been filled. • Check to see that the float in the burette is not occluding the flow of water from the burette. • Check to the see that the Tube Kit is correctly connected to the Probes. • Ensure that the tubing coming out of the bottom port of the burette is the portion that is in the pumphead. • Check for leaks or occlusions in the Tube Kit.

Pump is making abnormal noises

Check to see that the there is nothing in the pump that could be impeding the pump’s motion.

Pumps are running at different speeds

This is normal. The RF Generator will alter the pump speeds in order to maintain similar probe tip temperatures.

Pump stops during pretreatment cooling

This is normal. The RF Generator stops the pumps during pretreatment cooling for identification purposes.

Only one pump is rotating when both should be.

Check to see that you have enabled two Probes for treatment in the TRANSDISCAL* Disc Biacuplasty Advanced Settings on the RF Generator.

Customer Service and Product Return Information If you have any problems with or questions about HALYARD* COOLIEF* Cooled RF 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)

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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. 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 Probes 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 USA by Halyard Sales, LLC, Alpharetta, GA 30004; In USA, please call 1-844-425-9273 • halyardhealth.com Halyard Health, Inc., 5405 Windward Parkway, Alpharetta, GA 30004 USA 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 製造販売元 ハリヤード・ヘルスケア・インク 横浜市西区みなとみらい二丁目2番1号

*Registered Trademark or Trademark of Halyard Health, Inc., or its affiliates. © 2015 HYH. All rights reserved. Kimberly-Clark is a Registered Trademark of Kimberly-Clark Worldwide, Inc. 2015-12-28

15-H1-366-0-00/70169374

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