Instructions for Use Steriking Tyvek Self Seal Pouches

Instructions for Use: Steriking ® Tyvek Self Seal PouchesBrand Name of ProductGeneric Name of ProductProduct Code Number(s)Purpose of ProductSteriking ® Tyvek Self Seal Pouches, Manufactured by WipakPouchesLTSS1, LTSS2, LTSS4, LTSS4A, LTSS5A, LTSS6, LTSS7The STERIKING ® see-through self-sealable pouches are intended for use as packingmaterial for medical devices by vaporized hydrogen peroxide.Range of Applications for ProductKey specifications of product The STERIKING ® see-through packages are constructed of Tyvek ® that is heat-sealedtogether with a multiply PET/PE-plastic laminate (12/50 microns).Shipping Conditions & RequirementsStorage ConditionsPackaging ConditionsShelf LifeShipping & StorageIt is recommended that the STERIKING ® products are kept in the original, closed transportcarton and are stored in dry and clean conditions protected from direct sunlight, UV lightsources and excessive moisture.The shelf life is event-related and not time -related. It is recommended that the products areput to their end use within 3 years of manufacture. The recommended “best before” dateand the manufacturing date are stated on the carton label.Instructions for Using ProductDescription of Use (s) The STERIKING ® see-through self-sealable Tyvek ® pouches are intended for use aspacking material for medical devices by vaporized hydrogen peroxide.Preparation for Use 1. Before sealing, remove as much air as possible from the pouch. This will help preventrupturing in sterilization.2. Place the proper class of indicator inside the pouch according to your specific facilitiesguidelines.3. Ensure that pouch contents and the indicator are away from the seal area, and will notget caught in the seal.4. Seal the pouch securely.5. Leave enough space beyond the seal for the opener to easily grasp (usually 1- 1 ¼inches).6. Rubber bands, non-approved tape, safety pins, paper clips, staples or other sharpobjects should not be used to secure packages or to organize the contents.Diagrams (drawings, pictures):Steps for Use of Product 1. Remove protective strip2. Fold flap3. Press down from the center with both thumbs and move outward. Apply even presswhile moving thumbs. Repeat at least twice to ensure a proper seal.Interpretation of ResultsContraindications of Test ResultsDocumentation The STERIKING® See-Through range of peel packages conform to the internationalproduct standards and norms: ISO 11607-1:2006, ISO 11607-2:2006, EN 868-5: 2009. The products are registered under Class 1 as accessories in compliance with theEuropean Medical Device Directive MDD/93/42 which is incorporated in the FinnishAct 1505/94 and its statutes. To show compliance with MDD/93/42 the CE mark isprinted on the label of the transport carton. The products are registered by FDA under 510(k) Premarket Submission Nos.:K803293, K953776 and K973827. Wipak Oy is certified to ISO 9001:2000; ISO14001: 2004; OHSAS 18001: 1999; ISO 22000: 2005 and DS 3027: 2002. STERIKING® sterilization packages are designed, validated, and manufactured to suit

their intended purposes.Special Warnings and Cautions The STERIKING® Tyvek® pouches are meant for low temperature sterilization cyclesonly. Do not steam sterilize these pouches, as they will melt. Pouches should be stored in closed cabinets or otherwise protected from the UV-lightsource. The process indicator is sensitive to UV-light and may change color over time,if not stored properly.DisposalPlease refer to the local/national regulations regarding waste disposal.Reprocessing InstructionsPoint of use:Preparation for decontamination:Disassembly Instructions:Cleaning – Manual:Cleaning – Automated:Disinfection:Drying:Maintenance, inspection, and testing:Reassembly Instructions:Packaging:Sterilization: Compatible with vaporized hydrogen peroxide May be used in standard gas plasma cycles (validation data available online). Be sure to arrange pouches in such a way that there is minimal to no contact betweenpouches. If touching, arrange so that Tyvek® side is facing the plastic side. Chemical Indicator conforms to ISO 11140-1:2005 class 1: Process indicators.Vaporized Hydrogen Peroxide indicator changes from yellow/orange/shade of beige toa shade of blue on the outside of the pouch after Vaporized Hydrogen PeroxidesterilizationStorage: The sterilized products are sorted for storage or delivery to the wards. Pouches should be stored in closed cabinets or otherwise protected from the UV-lightsource. The process indicator is sensitive to UV-light and may change color over time,if not stored properly. It is recommended that the room climate has a humidity of 40% to 60% and atemperature of 15-25ºC.Additional Information:The products are for single use only.Related Healthmark ProductsOther Product Support DocumentsReference DocumentsCustomer Service contact:2013-10-22 msmithSterilization Packaging Brochure, Sterilization Packaging Price ListUS Distributor:Healthmark Industries Company, Inc33671 DorekaFraser, MI 480261-586-774-7600healthmark@hmark.comhmark.com