Boston Scientific

Model 6577 Telemetry Cleaning and Sterilization Guide

3 Pages

A Closer Look SUMMARY Boston Scientific repeated use products can be used more than once to support the implantation and monitoring of implantable cardiac devices, provided that proper cleaning and sterilization techniques are implemented prior to re-use. This article provides cleaning and sterilization techniques for certain Boston Scientific Repeated Use Products. Products Referenced Model 6577 Telemetry Wand, Model 6888 Lead Tunneler and Pulling Tips, Model 6860 Magnet, S-ICD System: Model 4520 Magnet, Model 3203 Telemetry Wand Products referenced are unregistered or registered trademarks of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners. Products referenced herein may not be approved in all geographies. Information is for the use in countries with applicable Health Authority product registrations. For comprehensive information on device operation, reference the full instructions for use found at: CAUTION: Federal (U.S.) law restricts this device to sale by or on the order of a physician. All graphics produced by Boston Scientific Corporation, unless otherwise noted. CRT-D: Cardiac Resynchronization Therapy Defibrillator CRT-P: Cardiac Resynchronization Therapy Pacemaker ICD: Implantable Cardioverter Defibrillator S-ICD: Subcutaneous Implantable Defibrillator  Contact Information  Americas Technical Services LATITUDETM Customer Support 1.800.CARDIAC (227.3422) +1.651.582.4000 Patient Services 1.866.484.3268  Europe, Middle East, Africa Technical Services +32 2 416 7222 LATITUDE Customer Support  Japan Technical Services LATITUDE Customer Support  Asia Pacific Technical Services +61 2 8063 8299  Cleaning and Sterilization of Repeated Use Products The cleaning and sterilization processes provided below are described in the applicable device labeling. Boston Scientific CRM has not conducted testing using any cleaning or sterilization methods on these products other than those described herein. Products designated as single-use only should not be reused or re-sterilized.  Model 6577 Telemetry Wand Cleaning − The exterior of the telemetry wand and cord can be cleaned with a soft cloth dampened with mild cleaning solution such as green soap, green soap tincture, Borax, or alcohol-free hand soap. − Use a fresh cloth dampened with sterile water to remove residue. − Air or towel dry. − Do not use an abrasive cloth or volatile solvents to clean any portion of the wand. − Do not use an ultrasonic cleaner. − Do not immerse the telemetry wand. − Do not allow any fluids to enter the wand cavity.  Sterilization CAUTION: The Model 6577 Telemetry Wand is shipped non-sterile. If the telemetry wand is to be used in a sterile field, it must be actively sterilized before use, or encased within a disposable sterile surgical sheath during use. NOTE: For example, a Model 3320 Intraoperative Probe Cover. CAUTION: Remove the telemetry wand from all packaging material before sterilization. Either ethylene oxide (EO) or steam may be used for active sterilization. Follow the cleaning instructions before beginning the sterilization process. Ethylene Oxide (EO) gas sterilization method: Follow the recommendations of the EO sterilization equipment manufacturer and allow the specified aeration time to fully elapse prior to use. Steam sterilization method: Follow customary autoclave procedures for wrapped goods and limit temperature to 132° C (-0°C, +5°C), 270° F (-0°F, +9°F). NOTE: The wand has been tested to withstand 25 sterilization cycles. Additional cycles are not recommended. The wand should be discarded if surface cracks appear in the plastic, and/or the cable discolors or becomes worn, regardless of the number of completed cycles.  LATITUDE Customer Support © 2015 by Boston Scientific Corporation or its affiliates. All Rights Reserved.  March 13, 2015  100000013782, Rev. A, US  Page 1 of 2
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