Tender LiV Care (TLC) Care and Handling Guide

Tender LiV™ Care (TLC)

ENGLISH BEFORE THE PROCEDURE

DURING THE PROCEDURE

AFTER THE PROCEDURE

Storage Transport

Preparation Storage

Cleaning, Lubrication, and Sterilization

Reference: Instructions for Reprocessing of Reusable Devices, P/N 440-11975-02

Before the Procedure • Store instruments in the proper tray at all times • Transport instruments in tray to avoid damage • Test function prior to use Contact Customer Service for replacements European Representative: Manufactured by: Köntges SPRL AtriCure Incorporated Avenue Hellevelt 35 7555 Innovation Way B-1180 Brussels Belgium Mason, Ohio 45040 USA Tel: +32 (0) 2 375 51 63 Customer Service: FAX: +32 (0) 2 375 89 06 1-866-349-2342 (toll free) e-mail: [email protected] 1-513-755-4100 (phone) During the Procedure • Flush instruments with saline periodically • DO NOT ALLOW BLOOD TO DRY ON INSTRUMENTS After the Procedure CAUTION! • Avoid caustic cleaners Cleaning solutions should be pH neutral • Avoid automated washers Instruments should be hand washed • Avoid tap water Use DI or RO water only • Avoid wet loads Instruments must be dry when stored Prior to Sterile Processing Department (SPD) • Hand rinse and flush with sterile water • Send to Sterile Processing Department (SPD) immersed in sterile water Cleaning at Sterile Processing Department (SPD) • Fill sink with Enzymatic Cleaner and de-ionized (DI) or reverse osmosis filtered (RO) water to manufacturer specifications • Immerse entire instrument in the sink • Using syringe with flush port adapter attached, flush instrument 2x or until no debris is seen exiting the instrument • Using soft cleaning brush, scrub jaws of instrument until clean • Actuate instrument to assure free movement and that all spots are clean • Rinse with DI or RO water • Flush with DI or RO water 2x or until no cleaner is present • Using air hose and compressed air, blow instrument dry (especially down the flush port) Lubrication • Lubrication of the device using Steris® Hinge-Free® instrument lubricant (or equivalent) per manufacturer’s instructions is recommended prior to each device sterilization cycle. Steam Sterilization • Please be sure to use DI or RO water • Pre-Vacuum, Steam Sterilization - 132 ºC (270 ºF) to 137 ºC (278.6 ºF) 4 Minutes (recommended) • Pre-Vacuum, Steam Sterilization - 134ºC (275 ºF) to 137 ºC (278.6 ºF) 3 Minutes Keep instruments in the proper tray at all times for transport to avoid damage - DO NOT STACK INSTRUMENTS ON EACH OTHER 490-13978-02 Rev. F

LiV™ Care and Handling Guide

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Disposal Method Follow local governing ordinances and recycling plans regarding or recycling of device components.

European Representative: Köntges SPRL Avenue Hellevelt 35 B-1180 Brussels Belgium Tel: +32 (0) 2 375 51 63 FAX: +32 (0) 2 375 89 06 e-mail: [email protected]

Manufactured by: AtriCure Incorporated 7555 Innovation Way Mason, Ohio 45040 USA Customer Service: 1-866-349-2342 (toll free) 1-513-755-4100 (phone)

Graphic Symbols for Device Labeling Catalogue Number

Serial Number

Quantity

Date of Manufacture

Manufacturer/Company Address

Authorized Representative in the European Union

Instrument supplied NonSterile

CE mark, Product conforms with the essential requirements in the European Medical Devices Directive 93/42/EEC.

Does not contain Natural Rubber Latex

Contains no di (2-ethylhexyl) Consult Instructions For Use phthalate (DEHP) released from polyvinyl chloride (PVC)

490-13978-02 Rev. F

LiV™ Care and Handling Guide

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician or other licensed practitioner.

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