Reprocessing Guide Stryker-Books Pdf

Reprocessing Guide Stryker
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User Guide EN 1, Guide de l utilisateur FR 13, Benutzerhandbuch DE 25. Manuale d uso IT 39, Manual do Utilizador PT 51, Gu a del usuario ES 63. Gebruikershandleiding NL 75, Brugervejledning DA 87. K ytt ohje FI 99, Brukerh ndbok NO 111, Anv ndarhandbok SV 123. Podr cznik u ytkownika PL 135, Introduction EN 2, Intended Use of Sterilization Trays EN 2.
Warnings EN 3, Cautions EN 3, Instructions EN 4, Sterilization Tray Setup EN 10. References EN 11, Introduction, This reprocessing guide provides instructions for the proper cleaning and sterilization. of the following sterilization tray, 272 700 000 Shaver Handpiece Tray. This sterilization tray is intended for use only with the devices listed below For tray. device configuration see the Sterilization Tray Setup section of this guide. Part Number Description, 375 708 500 Formula 180 Shaver Handpiece with buttons. 375 704 500 Formula Shaver Handpiece with buttons, 375 701 500 Formula Shaver Handpiece no buttons.
275 601 500 TPS Small Joint Shaver, While these instructions have been validated by the manufacturer as being capable. of preparing the tray for re use it remains the responsibility of the processor to. ensure that the reprocessing as actually performed using equipment materials. and personnel in the reprocessing facility achieves the desired result This normally. requires validation and routine monitoring of the process. Intended Use of Sterilization Trays, Sterilization trays are plastic and or metal containers used to hold and protect surgical. devices during the sterilization process They consist of an interlocking tray and lid. which are both perforated to allow the passage of sterilizing agent from outside the. tray to the devices placed inside, Sterilization trays typically feature a silicon finger mat or group of device holders that. secure devices during the sterilization process Some models feature stacking internal. trays to allow the segregation of devices, These instructions are validated only for sterilization of the tray and device s. identified herein Using combinations or parameters not described in this. manual may result in incomplete sterilization, These instructions do not replace the cleaning instructions provided with.
individual devices Prior to sterilization clean all devices as specified in their. respective user manuals, Wear appropriate protective equipment gloves eye protection etc when. reprocessing any medical device, Both the device and the tray must be cleaned prior to sterilization. or incomplete sterilization will result, The sterilization tray its lid and any internal components have been designed. and validated for use as a single system Do not separate components from. the system for use individually or in combination or incomplete sterilization. may result, Inspect the tray and its components for visible damage such as cracking or. chipping prior to use Do not use the tray if it is damaged. Before lifting the tray assembly verify that the latches connecting the lid to. the tray are secure, The tray is not designed for use as a shipping container To avoid damage.
remove all devices and pack them separately, Limitations on Proper processing has a minimal effect on the. Reprocessing tray End of life is normally determined by wear. and damage due to use, Do not cross sterilize the tray Using multiple. sterilization methods may significantly reduce, the performance of the tray. Do not leave the tray in solutions longer than, necessary This may accelerate normal product. Damage incurred by improper processing will, not be covered by the warranty.
Instructions, Instructions apply to the sterilization tray only For instructions on how to. reprocess the devices consult their respective instructions for use. Point of Use Wipe excess soil from the tray using disposable. paper towels, If an automated cleaning method will be. used rinse the tray in sterile distilled water, immediately after use. Containment and Reprocess device s tray as soon as reasonably. Transportation practical following use, Preparation for 1 Disassemble the tray into its individual. Manual Cleaning components base lid and if applicable silicon. 2 Prepare an enzymatic detergent1 according to, the manufacturer s recommendations.
3 Wipe the entire tray with a clean cloth dipped in. 4 Immerse the tray in the detergent, 1 Cleaning was validated using. Enzol at 1 oz gal at 35 40 C 5 Soak the tray in the detergent for 15 minutes. Manual Cleaning 1 Brush, Thoroughly brush the exterior of the tray with. a soft bristled brush focusing on any mated or, rough surfaces. Using a pipe cleaner and brush brush and flush, the hard to reach areas of the tray. Actuate the tray brushing any movable parts in, their extreme open and closed positions.
Rinse the tray with reverse osmosis deionized, RO DI water at ambient temperature to. remove all detergent residues After all, detergent residues have been removed. continue to rinse for a minimum of 30 seconds, Drain excess water from the tray and dry it. using a clean cloth and filtered pressurized air, Visually inspect the tray for cleanliness paying. close attention to hard to reach areas If visible, soil remains repeat steps 1 and 2.
Prepare a non enzymatic detergent2 according, to the manufacturer s recommendations. Fully immerse the tray and inject any mated, surfaces with at least 50mL of the detergent. Soak the tray for a minimum of 15 minutes, Thoroughly brush the exterior of the tray using. a soft bristled brush, Inject the prepared detergent into any mated. surfaces a minimum of five times, Actuate the tray brushing any movable parts in.
their extreme open and closed positions, Using a pipe cleaner and syringe brush and. flush the hard to reach areas of the tray, Thoroughly rinse the tray with ambient RO DI. water until all detergent residue is removed, Flush any crevices five times with a syringe. After the detergent residue is removed, continue rinsing for a minimum of 30 seconds. Drain the excess water from the tray and dry it, with a clean cloth and filtered pressurized air.
2 Cleaning was validated using, Renu Klenz at oz gal at Visually inspect the tray for cleanliness paying. 35 40 C close attention to hard to reach areas, Automated Cleaning 1 Rinse. Disassemble the tray into its individual, components the base lid and if applicable. silicon mat, Rinse the tray with RO DI water at ambient. temperature until there is no visible detergent, residue Use a syringe to assist in rinsing After.
all detergent residues have been removed, continue to rinse for a minimum of 30 seconds. Place the tray in the washer on an incline to, facilitate drainage. 2 Automated wash, Program the washer using the settings below. Recirculation Water Detergent, Time Temperature type and. concentration, Pre Wash 2 min Cold tap water, Enzyme 2 min Hot tap water Enzymatic.
Wash Detergent3, Wash 1 2 min Set point 60 C Non enzymatic. 140 F Detergent4, Rinse 1 2 min Heated 60 C, Dry Phase 7 min Drying Temperature. 115 C 239 F, Remove the tray from the washer after the. completion of the dry phase, Dry the tray using a clean soft cloth Use filtered. 3 Cleaning was validated using, Enzol at 1 oz gal, pressurized air 40 psi to assist in drying.
4 Cleaning was validated using Visually inspect the tray for cleanliness paying. Renu Klenz at oz gal close attention to hard to reach areas. Maintenance No routine maintenance is required for the. sterilization tray, Inspection and Inspect the tray for dents and cracks If a problem. Testing is observed or suspected the tray should be. returned for repair, Inspect all components for cleanliness If fluid. or tissue buildup is present repeat the above, cleaning and disinfection procedures. Packaging for Double wrap the tray unless otherwise. Sterilization noted below, Sterilization Prepare the device s and the sterilization tray. as indicated in the Sterilization Tray Setup, section below.
Sterilize the device s inside the tray according, to the parameters indicated below. Ethylene oxide EtO, Preconditioning Sterilization Aeration. Temperature 55 C 55 C 55 4 C, 131 F 131 F 131 7 F, Relative Humidity 70 70. Vacuum Set Points 1 30 psia, EtO Concentration 600 mg L. Time 60 minutes 240 minutes 12 hours, Follow the manufacturer s instructions to sterilize the device s and tray Select the.
appropriate cycle, STERRAD 100S and STERRAD Advanced NX. STERRAD NX, 375 708 500 Formula 180 275 601 500 TPS Small Joint. Shaver Handpiece Shaver, 375 704 500 Formula, Shaver Handpiece. 375 701 500 Formula, Shaver Handpiece, Autoclave Steam. Gravity Prevacuum Flash, Wrapping double double, Temperature 132 C 132 C 132 C.
270 F 270 F 270 F, Time 20 minutes 4 minutes 4 minutes. Dry Time 60 minutes 50 minutes, Warning Drying time depends on several. variables including altitude humidity type of, wrap preconditioning size of chamber mass of. load material of load and placement in chamber, Users must verify that drying time set in their. autoclave yields dry surgical equipment, Warning These instructions were developed.
using the guidance from AAMI TIR 12 ISO 17665, and AAMI ST79 and Stryker recommends users. observe these standards, Storage Trays with non absorbent liners such as plastic. or silicone fingered organizing mats can cause, condensate to pool To preserve sterility remove. devices from standing solution, Additional N A, Information. Sterilization Tray Setup, Maximum 1 52 kg 3 35 lbs.
Weight Load, devices and tray, Internal Stacking No internal stacking is permitted with this tray. External Stacking Do not stack other trays or devices on or below this. Accessories There are no accessories available for use with this tray. Device Distribution Devices should be placed in the tray as illustrated. Chemical Indicator, Place the chemical indicator in the bottom left. corner of the tray as illustrated in the following picture. Biological Indicator, Place the biological indicator on device tip as. illustrated in the following picture, Note Placement of the biological or chemical indicator is not required during sterilization of this tray. If per hospital procedure placement of an indicator is desired the recommended placement sites are. as follows, References, ISO 17664 Sterilization of medical devices Information to be provided by the.
manufacturer for the processing of resterilizable medical devices. ISO 17665 1 Sterilization of health care products Moist heat Part 1. Requirements for the development validation and routine control of a sterilization. process for medical devices, ANSI AAMI ST77 Containment devices for reusable medical device sterilization. ANSI AAMI ST79 A comprehensive guide to steam sterilization and sterility. assurances in health care facilities, ANSI AAMI ST81 Sterilization of medical devices Information to be provided. by the manufacturer for the processing of resterilizable medical devices. AAMI TIR12 Designing testing and labeling reusable medical devices for. reprocessing in health care facilities a guide for device manufacturers. EN 2 Introduction This reprocessing guide provides instructions for the proper cleaning and sterilization of the following sterilization tray 272 700 000 Shaver

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