entellus Medical

3484-001 FocESS Sinuscope Sterilization Tray Instructions for Use

3 Pages

FocESS™ Sinuscope Sterilization Tray 3484-001 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 Storage					3 Warranty					3  READ THIS SECTION BEFORE PLACING PRODUCT INTO SERVICE Indications for Use: The FocESS™ Sinuscope Sterilization Tray is used to organize and protect the FocESS Sinuscopes that are sterilized by a healthcare provider. The FocESS Sinuscope Sterilization Tray is intended to allow sterilization of the enclosed medical devices during these sterilization cycles : • pre-vacuum steam • STERRAD® 100S Standard • STERRAD® 100NX Standard • ethylene oxide 		 • STERRAD® NX Standard		 • STERRAD® 100NX Express 				 			 			 The Tray is intended to be used in conjunction with a legally marketed wrap. The Tray is not intended on its own to maintain sterility.  Device Description: The FocESS Sinuscope Sterilization Tray is used to enclose and hold the FocESS Sinuscopes 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 » Ethylene Oxide (EO): » Autoclave Sterilization Parameter:				 Preconditioning Parameters: Cycle : Pre-vacuum						 Temperature: 131°F (55°C) Temperature : 270° F (132° C)					 Relative Humidity: 70± 15% Exposure Time : 4 minutes					 Time: 1 hour Minimum Dry Time : 30 minutes					  Limitation on Processing  Sterilization Parameter: Temperature: 131°F (55°C) Minimum Exposure Time: 120 minutes Minimum Aeration Time: 12 hours  » STERRAD® 100S Standard Cycle » STERRAD® 100NX Standard Cycle » STERRAD® NX Standard Cycle » STERRAD® 100NX Express Cycle  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.  1
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File Name: entellus Medical - 3484-001 FocESS Sinuscope Sterilization Tray Instructions for Use - 2016-03 - Rev A.pdf

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