DJO GLOBAL

Instruments and Instrument Cases Care and Handling Recommendation

32 Pages

DJO Surgical® Instruments and Instrument Cases Instrumente und Instrumentenbehälter von DJO Surgical® Instruments chirurgicaux et boîtiers à instruments DJO Surgical® Instrumentos y estuches de instrumentos quirúrgicos de DJO Surgical® Strumenti chirurgici e custodie DJO Surgical® Χειρουργικά όργανα και θήκες οργάνων DJO Surgical® DJO Surgical® Aletleri ve Alet Kutuları ______________________________________________________  Encore® Medical, L.P. 9800 Metric Blvd. Austin, TX 78758-5445 USA MDSS GmbH Schiffgraben 41 30175 Hannover, Germany  Distributors for countries where DJO is not the distributor: Country Distributor Name South Korea BioImplant Technology Denmark  Innosurge Trauma  Belgium  Orthogrow Distribution  South Africa  MedHold  Mexico  Daonsa  Columbia  Piemca-Venezuela / Piemca-Columbia  Saudi Arabia  Al-Ewan Medical Company  Turkey  Armoni Medikal  Distributor Address 1029 Yeongdeok-dong, Giheung-gu, Yonngin-si, Gyeonggi-do, Korea, 16950 #2101 U-Tower Alsikevej 16 DK-8920 Randers NV DaVincilaan 1 1930 Zaventem Belgium MSI Business Park 68 Rigger Road Spartan Kempton Park Gauteng 1619 Miguel Hidalgo 2426 Pte, Obispado, 64010 Monterrey, N.L., Mexico Cra. 15 No. 88 - 64 / Edificio Torre Zimma / Oficina 705 y 713 Bogotá D.C., Colombia Prince Nasir Ibn Farhan Al Saud, Al Mursilat, Riyadh 12461, Saudi Arabia Gazi Mahallesi Yavuz Kanat Sok. Pasifik Plaza No. 34 Yenimahalle 06560 Ankara, Turkey  0400-0146 Rev. YE 2021-06 A printable copy of the IFU for this device can be located at: www.djosurgicalifus.com. A paper copy can be requested via phone at +1-800-520-8976. EN 1. Product Handling Devices not returned to DJO should be treated as biohazardous material and disposed of in accordance with local laws and regulations .  REUSABLE INSTRUMENT DESCRIPTION  Recommendation for the Care and Handling for DJO Surgical® Instruments and Instrument Cases DJO Surgical® instrumentation consists of devices and their accessories used in surgical procedures. Implantation of DJO Surgical® products should only be performed with DJO Surgical® instrumentation or instrumentation distributed by DJO Surgical®. DJO Surgical® instruments and instrument cases are generally composed of titanium, stainless steel, aluminum, and/or polymeric materials. The cases may be multi-layered with various inserts to hold surgical instrumentation in place during handling and storage. The inserts may consist of trays, holders, and silicone mats. The instrument cases will allow sterilization of the c ontents to occur in a steam autoclave utilizing the cleaning, sterilization, and drying cycle that has been validated and detailed below. Instrument cases do not provide a sterile barrier and must be used in conjunction with FDA cleared sterilization wrap to maintain sterility. Instruments are provided non-sterile and should be stored in their original packaging until cleaned and sterilized according to the recommended guidelines listed below.  WARNINGS  Automated cleaning may not be thorough enough. Carefully inspect each instrument to ensure that all visible blood residue and other contaminants have been removed.  CAUTION  Federal Law (USA) restricts this device to sale by or on the order of a physician.  REPROCESSING LIMITATIONS  DJO Surgical® instruments can be steam sterilized and repeat sterilization will not adversely affect them. If problems related to instrument sets are identified when using our instruments or instrument cases, please bring it to the attention of DJO Surgical® for investigation. The lifetime of an instrument is typically limited by normal wear and damage due to use.  DISCLAIMER  DJO Surgical® instrument cases are intended to protect instrumentation and facilitate the sterilization process by allowing steam penetration and drying. DJO Surgical® has verified through laboratory testing that our instrument cases are suitable for the sterilization cycles listed in the sterilization section of the IFU. It is the user’s responsibility to verify that equipment is performing as intended, and conditions are achieved.  PAGE 1 OF 32  FORM 1000.3004.02 Rev. A
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