entellus Medical

3483-001 MiniFESS Sterilization Tray Instructions for Use

3 Pages

MiniFESS™ Sterilization Tray 3483-001 INSTRUCTIONS FOR USE TABLE OF CONTENTS SUBJECT			  The instructions provided within have been validated by the device manufacturer as being capable of reprocessing reusable medical devices. Individual sterilizers, instrument cleanliness, specific loading of instrument trays, types and geometry of instruments, sterilization containers, filters and wrappings vary at each location.  PAGE  Read First				 Indications for Use			 1 Device Description			 1 Sterilization Methods and Configurations 1 Limitations				1-2 Warnings					2 Universal Precautions			2 Points of Use				2 Cleaning					2 Disinfection				2 Maintenance, Inspection and Testing		 2 Sterilization				2-3 Storage					3 Warranty					3  READ THIS SECTION BEFORE PLACING PRODUCT INTO SERVICE Indications for Use: The MiniFESS™ Sterilization Tray is used to organize and protect the MiniFESS instruments that are sterilized by a healthcare provider. The MiniFESS Sterilization Tray is intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycle. The Tray is intended to be used in conjunction with a legally marketed wrap. The Tray is not intended on it’s own to maintain sterility.  Device Description: The MiniFESS Sterilization Tray is used to enclose and hold the MiniFESS instruments in an organized manner during the sterilization process and subsequent storage and transportation. The tray does not have direct patient contact. The tray by itself does not maintain sterility. The tray is composed of aluminum and has a rectangular base with latchable cover. The tray has perforations to allow sterilant penetration. The tray contains silicone instrument holders in the base and/or cover to hold, organize and protect the surgical instruments within the tray during the sterilization process and subsequent storage and transportation.  Sterilization Methods and Configurations » Autoclave Sterilization Parameter: Cycle : Pre-vacuum Temperature : 270° F (132° C) Exposure Time : 4 minutes Minimum Dry Time : 30 minutes  Limitation on Processing 1)  The end of useful life on the Tray is a minimum of 25 sterilization cycles. Inspect the tray before use for wear and damage caused by use and discontinue use if visible signs of wear are present including corrosion, mechanical failures, cracking, peeling, flaking, broken welds, damaged feet, damaged latches, damaged Hold-It / Hold-Down, discoloration, etc.  2)  See TABLE 2 for sterilization methods and configurations.  3)  DO NOT OVERLOAD the Tray or components.  4)  DO NOT OVERLOAD individual Hold-It slots. Load only one instrument per Hold-It slot.  5)  Inside of sterilizers, DO NOT STACK individually wrapped Trays or components. Separate wrapped Trays or components from each other or any other items on separate shelves of the sterilizer to allow for maximum sterilant flow.  6)  The use of non absorbent tray liners (ie. silicone fingered organizing mat) can cause condensate to pool. If visible moisture is present, re-sterilize with a longer dry time.  1
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File Name: entellus Medical - 3483-001 MiniFESS Sterilization Tray Instructions for Use - 2016-03 - Rev A.pdf

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