COOLIEF MULTI-COOLED Radiofrequency Module Instructions for Use Dec 2016

Fig. 1 Top View of COOLIEF* Multi-Cooled RF Module COOLIEF* Pump Connector Cable COOLIEF* Generator

COOLIEF* Peristaltic Pump Unit

COOLIEF* Multi-Cooled RF Cable

Dispersive Electrode

COOLIEF* Cooled RF Introducer A

COOLIEF* Cooled RF Sterile Tube Kit Fig. 2 Connecting One Probe to COOLIEF* Multi-Cooled RF Module

COOLIEF* Cooled RF Probe A

COOLIEF* Pump Connector Cable COOLIEF* Generator

COOLIEF*Peristaltic Pump Unit COOLIEF* Cooled RF Probe B COOLIEF* Multi-Cooled RF Cable

Dispersive Electrode

COOLIEF* Cooled RF Introducer B COOLIEF* Cooled RF Introducer A

COOLIEF* Cooled RF Sterile Tube Kit Fig. 3 Connecting Two Probes to COOLIEF* Multi-Cooled RF Module

COOLIEF* Cooled RF Probe A

COOLIEF* Pump Connector Cable COOLIEF* Peristaltic Pump Unit COOLIEF* Cooled RF COOLIEF* Cooled RF Introducer C Sterile Tube Kit

COOLIEF* Generator

COOLIEF* Cooled RF Probe C COOLIEF* Multi-Cooled RF Cable

Dispersive Electrode

COOLIEF* Cooled RF Sterile Tube Kit Connecting Three Probes to Fig.4 to COOLIEF* Multi-Cooled RF Module

COOLIEF* Generator

Dispersive Electrode

Rx Only

COOLIEF* Cooled RF Introducer B COOLIEF* Cooled RF Introducer A COOLIEF* Cooled RF Probe A

COOLIEF* Pump Connector Cable COOLIEF*Peristaltic Pump Unit COOLIEF* Cooled RF Sterile Tube Kit

COOLIEF* Cooled RF Probe D COOLIEF* Cooled RF Introducer D COOLIEF* Cooled RF Introducer C

Multi-Cooled RF Cable

COOLIEF* Cooled RF Probe C COOLIEF* Cooled RF Probe B

COOLIEF* Cooled RF Sterile Tube Kit

COOLIEF* Cooled RF Introducer B COOLIEF* Cooled RF Introducer A COOLIEF* Cooled RF Probe A

Connecting Four Probes to Fig.4 to COOLIEF* Multi-Cooled RF Module

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COOLIEF* Cooled RF Probe B

Caution

Consult instructions for use

Dispose of properly

HALYARD* COOLIEF*

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

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Device Description

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The HALYARD* COOLIEF* Multi-Cooled Radiofrequency (RF) Module is used in conjunction with a HALYARD* COOLIEF* Cooled Radiofrequency (RF) Pain Management Generator V4.0 or higher or Kimberly-Clark® Radiofrequency Generator V4.0 or higher (PMG-115-TD/PMG-230-TD/PMG-ADVANCED) and COOLIEF* Cooled Radiofrequency Probe(s) (SIP/LUP/THP) to create radiofrequency (RF) lesions in nervous tissue. (Fig. 1)

Indications For Use The HALYARD* COOLIEF* Multi-Cooled Radiofrequency Module will be used in conjunction with a radiofrequency generator to create lesions in nervous tissue.

Contraindications 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 radiofrequency lesion 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

The COOLIEF* Multi-Cooled RF Module is a reusable device. Failure to properly clean the device can cause patient injury and/or the communication of infectious diseases from one patient to another. The COOLIEF* Multi-Cooled RF Module must be used with the correct version of the HALYARD* COOLIEF* Cooled Radiofrequency (RF) Pain Management Generator V4.0 or higher (PMG-115-TD/PMG-230-TD/ PMG-ADVANCED). Attempts to use it with other connector cables can result in electrocution of the patient or operator. Laboratory staff and patients can undergo significant x-ray exposure during radiofrequency 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 the RF Generator is activated, the conducted and radiated electrical fields may interfere with other electrical medical equipment. Do not use the COOLIEF* Multi-Cooled RF Module with the Bipolar Adaptor (PMA-BP).

Precautions • • •

Do not attempt to use the COOLIEF* Multi-Cooled RF Module before thoroughly reading these Instructions For Use and the User’s Manual for the RF Generator. The COOLIEF* Multi-Cooled RF Module should be used by physicians familiar with radiofrequency lesion techniques. Apparent low power output or failure of the equipment to function properly at normal settings may indicate: 1) faulty connection of the system or 2) power failure to an electrical lead. Do not increase power level before checking for obvious defects or misapplication.

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In order to prevent the risk of ignition make sure that flammable material is not present in the room during RF power application. The RF Generator is capable of delivering significant electrical power. Patient or operator injury can result from improper handling of the Probe and DIP electrode, particularly when operating the device. During power delivery, the patient should not be allowed to come in contact with ground metal surfaces. It is the physician’s responsibility to determine, assess and communicate to each individual patient all foreseeable risks of the radiofrequency lesion procedure.

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

Product Specifications HALYARD* COOLIEF* Multi-Cooled Radiofrequency Module Model Enclosure Dimensions COOLIEF* Multi-Cooled RF Cable (Length) Number of Connections Operational temperature Storage temperature Humidity

CRX-BAY-MCRF 3.3 in. x 2.5 in. x 0.9 in. 8 ft. 4 10°C to 40°C -40°C to 70°C 15-80% non-condensing

Inspection Prior To Use Prior to use the following inspections should be completed: 1. Inspect the COOLIEF* Multi-Cooled RF Module for any signs of physical damage to the enclosure or to the Cable. 2. Inspect the COOLIEF* Multi-Cooled RF Module for damaged insulation or connectors. 3. Inspect both the COOLIEF* Multi-Cooled RF Enclosure and Cable to see that labels are present and legible.

Equipment Required The COOLIEF* Multi-Cooled RF Module is for use in RF procedures performed in specialized clinical settings. The equipment required for these procedures are as follows: • Radiofrequency Generator V4.0 or higher (PMG-115-TD/PMG-230-TD/ PMG-ADVANCED) • COOLIEF* Cooled RF Probe (SIP/THP/LUP) • COOLIEF* Cooled RF Introducer (SII/THI/LUI) • Disposable Indifferent (dispersive) Patch (DIP) Electrode

Instructions For Use Carefully read all instructions prior to use. Observe all contraindications, warnings and precautions noted in these instructions. Failure to properly follow instructions may lead to improper functioning of the device and result in patient injury. 1. Place the COOLIEF* Multi-Cooled RF Module on a mounting cart or on any sturdy table or platform. Attach the COOLIEF* Multi-Cooled RF Cable to the RF Generator. 2. Connect the COOLIEF* Cooled RF Probe(s) to the connectors on the COOLIEF* Multi-Cooled RF Module. Up to four COOLIEF* Cooled RF Probes (SIP/THP/LUP) may be connected to the COOLIEF* Multi-Cooled RF Module. (Fig. 2-5) Follow the Instructions For Use for the COOLIEF* Cooled-RF Probe (SIP/THP/LUP) when connecting and placing the probes, as well as during the placement of the Disposable Indifferent (dispersive) Patch (DIP) Electrode. 3. Stimulate each probe individually as necessary by following the RF Generator V4.0 User’s Manual. 4. Lesion as necessary by switching the RF Generator to the lesion mode. Refer to the RF Generator V4.0 User’s Manual for more information on lesioning. 5. Set up the rest of the System as per the COOLIEF* Cooled RF Probe (SIP/THP/LUP) Instructions for Use.

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Cleaning and Sterilization Instructions

Customer Service and Product Return Information

The COOLIEF* Multi-Cooled RF Module is a non-body contact device and therefore is NOT sterile and CANNOT be sterilized. If cleaning is necessary, the surface of the Module can be cleaned with a damp low-lint cloth with non-abrasive detergent dissolved in water. Dry the surface after wiping down. NEVER spray or pour liquids directly on the COOLIEF* Multi-Cooled RF Module.

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)

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

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Notes

PROBLEM

COMMENTS

TROUBLESHOOTING

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

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

In order to measure temperature, all devices must be in good working order.

• Ensure that all equipment required is correctly connected. • Check for an error message on the RF Generator. • Visually inspect the probe(s) and cable(s) for damage. Ensure that devices are dry and at room temperature. If problem persists, discontinue use.

Limited Warranty

No impedance measurement in ready state

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

• Ensure that all equipment required is correctly connected. • Check for an error message on the RF Generator. • Visually inspect the probe(s) and cable(s) for damage. Ensure that devices are dry and at room temperature. If problem persists, discontinue use.

Probe Connector does not fit in Probe Plug-In

Each connector 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 keys are lined up in the proper orientation. • Check that the connectors being connected have the same number of pins and that the pins are not damaged. The COOLIEF* Multi-Cooled RF Module is only to be connected to Cooled RF Probes (SIP/ THP/LUP). • Ensure that the connectors are clean and unobstructed.

RF Generator Connector does not fit in RF Generator Plug-in

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

• Check that the connector keys are lined up in the proper orientation. • Check that the connectors being connected have the same number of pins and that the pins are not damaged. The COOLIEF* Multi-Cooled RF Module is only to be connected to the RF Generator V4.0 or higher, featuring a 19-pin connector. • Ensure that the connectors are clean and unobstructed.

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 as previously mentioned. 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.

www.halyardhealth.com

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. 2016-12-18

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