A Sterile Processing User s Guide

Transcription

1 Product Manual A Sterile Processing User s Guide Safety, Assurance, Innovation, & Quality enabling perioperative professionals to achieve higher standards of performance and enhanced patient safety Phone:866-ONE-TRAY Copyright All rights reserved. Not to be duplicated without express permission of the author 1

2 ContentsII and proprietary Welcome to ONE TRAY...3 ONE TRAY System Configurations...4 Sterilization Guidelines...5 Care & Use of Your ONE TRAY System Preparation...6 Opening.. 7 Filter Installation....8 Loading..10 Closing & Seal Installation Sterilization & Handling..14 Opening...15 Removing Contents Inspection Checklist Disassembly. 17 Cleaning Warranty Proudly Made in the U S A 2

3 Welcome to ONE TRAY Just-In-Time Terminal Sterilization System We very much appreciate your decision to purchase the ONE TRAY Sealed Container System. ONE TRAY Sealed Containers are 510(k) cleared by the FDA for the rapid sterilization of temperature tolerant surgical devices; includes a 48 hour shelf. ONE TRAY Sterilization Containers are intended for the terminal sterilization of surgical devices and supplies; including instrumentation with lumens 3mm in diameter or larger, with lengths up to 400mm.,In addition, ONE TRAY complies with AAMI and AORN guidelines for the safe transport and assured delivery of the contents with tamper evident security in a sealed container. ONE TRAY containers are a reusable device with base, cover, and deck plate constructed of hard anodized aluminum to prevent corrosion. With proper care and handling, ONE TRAY will provide many years of effective and reliable service. The performance and intended use of ONE TRAY Sealed Sterilization Containers should comply at all times with the methods of use and sterilization guidelines as recommended by AAMI (Association for the Advance of Medical Instrumentation), AORN (Association of perioperative Nurses), ASHCSP (American Society of Healthcare Central Service Professionals), NIHSPO (National Institute for the Certification of Healthcare Sterile Processing and Distribution Personnel), IAHCSMM (International Association of Healthcare Central Service Material Management) and the manufacturer of those devices being sterilized. Proudly Made in the U S A by 3

4 is available in the following components and configurations: Product # ONE TRAY 21 Model Description M long x 12 wide 4 working height M-2106 M-2108 Product # M-2404 M long x 12 wide 6 working height 21 long x 12 wide 8 working height ONE TRAY 24 Model Description 24 long x 12 wide 4 working height 24 long x 12 wide 6 working height M long x 12 wide 8 working height Product # ONE TRAY Accessories Description OTK-210 RPS-004 RPS-005 RPS-015 RPS-030 RPS-055 RPS-100 ONE TRAY Processing Kit 100 kits per box, 2 boxes per case Each kit contains - 3 Hydrophobic Filters, Class 5 Integrator, 2 Load I. D. cards w Indicator Dot & 2 Tamper Evident Seals. RAPID Processing Solution RAPID Processing Solution Case of Four 1 Gallon Bottles RAPID Processing Solution Five Gallon Pail RAPID Processing Solution Fifteen Gallon Drum RAPID Processing Solution Thirty Gallon Drum RAPID Processing Solution Fifty five Gallon Drum RAPID Accurate Measure Hand Pump Proudly Made in the U S A 4

5 Just-In-Time Terminal Sterilization ONE TRAY is validated and 510(k) cleared for the rapid processing of temperature tolerant surgical instrumentation by gravity or pre-vacuum sterilization cycles with a total gross weight (container plus contents) not to exceed 25 lbs. This includes sterilization of lumens of 3 mm in diameter, or larger; with lengths of up to 400 mm according to the times and temperatures listed. ONE TRAY is 510(k) cleared by the FDA only for use in the following cycles as established during validation testing performed in an AAMI ST-08 compliant steam sterilizer: Steam Sterilization Cycles Pre-Vacuum Temperature 270 F Exposure Time 4 Minutes Cycle Dry Time Not Required Cycle Cool Time Not Required Gravity Temperature 270 F Exposure Time Minutes Cycle Dry Time Not Required Cycle Cool Time Not Required (do not process ONE TRAY using pulsed flash cycles) Items rapidly processed in ONE TRAY have a 30 Day Shelf Life! 5

6 Preparation 1. Thoroughly inspect container for dents or damage that may affect performance. 2. Place container on stable and level surface at height that facilitates safely opening the cover 3. Open the container by removing the cover according to the instructions illustrated in the table on the next page. 4. Confirm the rim of container base is free of burrs and dents. 5. Inspect to insure lid gasket is free of cracks, tears, imperfections or defects and is completely seated in channel. 6. Confirm that the cover properly mounts on container base and seals in place. 6

7 Opening Method 1 2 Cover on base with latch handles in locked position Grasp cover latch handles at each end of container 3 4 Simultaneously pull out and upward on cover latch handles at each end Latch is disengaged from base as the cover latch handles are raised 5 6 Clasp releases from the base as both cover latch handles are raised Latch handles are fully open and cover removed from base 7

8 The validated performance and 510(k) Clearance of ONE TRAY is in effect ONLY with the exclusive use of ONE TRAY Processing Kits and deck plate. Filter Installation 1. A single disposable ONE TRAY filter element is required for each of the vented areas (one in container lid and two in container base). 3. Each disposable filter element should be inspected to confirm the absence of imperfections or defects such as puncture holes or tears, etc. 4. Each disposable filter element must completely cover the grooved channel surrounding the vented area. 5. Confirm the notched end of filter cover is properly oriented with either set of stand-off posts. 6. Insert notched end of filter cover under stand-off posts. 7. Position keyholes in filter cover slide-bar over an opposing set of stand-off posts. 8. Apply downward pressure on filter cover and push the slide bar completely forward into a fully locked position under the standoff posts. Use all of the items contained in the ONE TRAY Processing Kit For each processing cycle. 8

9 Filter Installation 1 2 Use ONE TRAY Processing Kit Confirm vent gasket is clean and undamaged 3 4 Position filter to completely cover the vent gasket Insert notched end of filter cover under stand-off posts 5 6 Position keyholes in slide-bar over the stand-off posts 9 Apply downward pressure and move the side-bar into the locked position

10 Loading the Container 1. ALWAYS prevent contents from contacting the cover. 2. Avoid obstructing the vent and filter cover with pliable items. 4. Per AAMI guidelines, a chemical indicator or integrator should be used within each assembled set according to organizational policy. ONE TRAY recommends the use of a Class 5 Multi-Parameter Steam Sterilization Integrator with all rapid sterilization cycles. 5. When loading the container, only the ONE TRAY deck plate has been specifically designed for the direct placement of items or insertion of modular instrument organizing trays. Complex instruments should be prepared and sterilized according to the manufacturers written instructions 10

11 Container Assembly & Security 1. Inspect rim of container to confirm there are no dents or burrs. 2. Inspect cover gasket to confirm there are no cracks, tears, imperfections, or defects. 3. Confirm that all filter covers are securely in place. 4. Place cover on container base evenly and confirm proper fit between cover and base. 5. Secure cover by simultaneously pressing down to engage the latch at each end. 6. Properly complete both content I. D. cards and insert into slot on latch plate at each end of container. 7. Insert a ONE TRAY tamper evident seal through the latch at both ends of container. The validated performance and 510(k) Clearance of ONE TRAY is in effect ONLY with the exclusive use of ONE TRAY Processing Kits and deck plate. 11

12 Seal Method 1 2 Insert narrow end of seal through the bracket Position tagged end of seal in bracket 3 4 Gasp narrow end of seal Insert narrow end of seal into flat side of seal 5 6 Push narrow end through opening on tag Seal placed on bracket at both ends of container 12

13 Sterilization & Handling 1. Place a single ONE TRAY container in a level horizontal position on each shelf within the sterilizer. 2. Confirm that all vented areas are not obstructed. DO NOT STACK DURING STERILIZATION 3. ONE TRAY is validated for rapid processing by gravity or prevacuum sterilization of total gross weight (container plus contents) not to exceed 25 lbs. This includes sterilization of lumens of 3 mm in diameter or larger with lengths of up to 400 mm. ONE TRAY is validated for use in the following cycles: Pre-vacuum F Gravity F CAUTION! 4. Following sterilization avoid unprotected contact with the hot container by using insulated handles to lift and transport. 5. After each Sterilization Cycle retain any Steam Integrators used. 6. Retained condensed moisture is normal and expected and may vary by by load composition does not compromise the sterility of contents. Items rapidly processed in ONE TRAY have a 30 Day Shelf Life! 13

14 Closing Method 1 2 Align the cover with base Mount the cover properly onto the base 3 4 Position lid onto base with latch handles in upright position Simultaneously lower both latch handles into horizontal position 5 6 Push down on both handles to fully engaged clasp Container is sealed when both latch handles are in locked position 14

15 Sterile Delivery & Presentation 1. Place container on level and stable surface at height that facilitates aseptic opening. 2. Check that external dot indicators on the load content card(s) have turned the appropriate color. 3. Inspect load content card(s) to verify identification of the correct Instrument set. 4. Check to insure tamper proof seals are intact by gently tugging on each seal. 6. Before opening, inspect container and confirm presence of filters in all three vents. 7. Place thumbs on upper surface of cover above latch handles. 8. Place fingers under lid latch handles at both ends of container. 9. Break the tamper evident seals by firmly and simultaneously pulling up on both lid latch handles. 10. Aseptically lift cover off the base of the container and inspect for proper placement of filter and installation of filter cover on lid. 11. Remove lid filter cover and confirm filter is undamaged. All clinical research and validation testing of ONE TRAY Containers was performed with ONE TRAY components, filter elements and tamper evident seals. 15

16 Removing Sterile Contents 1. Before touching the insert tray or contents of the container, properly trained personnel must check internal sterilization indicators following facility guidelines to verify acceptable results. 2. Securely grasp the contents, or modular organizing tray handles and remove in an aseptic manner without touching the outside of the container. 3. Before placing contents on the sterile field, properly trained personnel must inspect the placement of both filter retention plates and integrity of each filter element on both vents in the floor of the container base. 4. After container is empty, replace the container lid and secure the clasps to the container base using the latch handles. Inspection Check List Contents should be considered non-sterile if any of the following conditions are present: A tamper evident seal is not intact or is missing from either latch. A filter retention plate is dislodged. A filter does not completely cover the vented area. Integrity of a filter element has been compromised (i.e. punctured, torn, etc.). Lid gasket is damaged or not properly seated in channel. Lid and or base are damaged and do not seat properly. 16

17 Disassembly 1. Remove and discard all disposables (filters, load content cards, etc.). 2. Inspect container cover and base for dents or damage that may affect performance. 3. Confirm the rim of the container base is free of burrs and dents. 4. Inspect that cover gasket is free of cracks, tears and is properly seated in channel on the cover. 5. Confirm that cover properly fits on container base. Cleaning 1. ONE TRAY containers and components may be safely processed in a mechanical washer/decontaminator, cart washer or processed manually. 2. Mechanical or automatic processing should follow the directions of the equipment manufacturer with ONE TRAY cover and base positioned to prevent water collection. 3. For optimal cleaning results use a neutral ph detergent. 4. NEVER clean the container with abrasives or wire brushes. 5. All components should be secured or enclosed inside a rack or basket with no protrusions to prevent damage during processing. 6. Confirm that all components are cool before handling. 7. If necessary, dry container and components by wiping with a soft dry cloth. 17

18 Appendix Manufacturer s Warranty ONE TRAY Sealed Sterilization Containers are guaranteed for the life of the product to be free of functional defects in workmanship and materials when used normally as recommended for their intended purpose in conjunction with ONE TRAY filters, tamper evident seals, and deck plate. The cover gasket is warranted for a period three years from the date of purchase. Any product determined to be defective upon delivery will be repaired or replaced with no charge to the customer at the sole discretion of ONE TRAY. Used product may not be returned for credit. Any and all returns must receive prior authorization from ONE TRAY and include documentation that the returned product was properly cleaned and decontaminated. This warranty is valid only to the original purchaser. The following exclusions apply to this warranty that include, but are not limited to: Conditions resulting from; negligence, misuse and improper cleaning, handling, closing or opening. Use of accessories (tamper evident seals, filters, etc.) not supplied by ONE TRAY. Damage from excessive force or pressure. Use of abrasive cleaning agents or harsh detergents that are not neutral ph. Modification(s) to the container. Effects from fire, flood or other unpredictable event not under the control of ONE TRAY. LIMITS OF USE ONE TRAY containers have been validated to perform for five hundred steam sterilization cycles. The actual limits of reuse for the ONE TRAY are based upon the proper handling, use, care and cleaning of the ONE TRAY. Users may experience limits that are greater or less based upon their use of the ONE TRAY. 18