SterilContainer S for use in the Steris V-PRO 60 Low Temperature Sterilization System

Transcription

1 SterilContainer S for use in the Steris V-PRO 60 Low Temperature Sterilization System This document contains Instructions for Use regarding the processing of the SterilContainer S prior to sterilization in the Steris V-PRO 60 sterilizer. Description: The SterilContainer S is a container system that will allow for sterilization and storage of medical devices. This container system is for use in low-temperature sterilization technology such as with the Steris V-PRO the Steris V-PRO 60 Sterilization System. The SterilContainer S rigid containers are made from non-anodized Aluminum and utilize disposable (single use) polypropylene filters. The SterilContainer S includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamperevident locks. Indications for Use: The SterilContainer S is a reusable sterilization container system (consisting of perforated bottoms and perforated lids with filter retention plates, and single use polypropylene filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. This container system has been validated with stainless steel and Teflon lumens, hinged, and knurled instruments. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use with the V-PRO 60 Low Temperature Sterilization System s Lumen, Non Lumen and Flexible Cycles. The SterilContainer S includes accessories such as silicone mats, baskets, trays, racks, eyepiece holders and sleeve holders. The SterilContainer S was demonstrated to maintain the sterility of its contents for 180 days following successful sterilization. V-PRO 60 Sterilizer Lumen Cycle Lid Bottom Description Total loaded container weight (lbs) Intended Container Load JM440 Full Size 90mm (4 ¼ )* Lumened and non-lumened devices with diffusion-restricted spaces such JM489 JM441 Full Size 120mm (5 ½ )* as the hinged portion of forceps and JM442 Full Size 135mm (6 )* scissors Medical devices, including single, dual JM740 ¾ Size 90mm (4 ¼ )* and triple channeled rigid and semirigid JM789 JM741 ¾ Size 120mm (5 ½ )* endoscopes, with the following configurations: JM742 ¾ Size 135mm (6 )* single or dual lumen devices with stainless lumen(s) that is (are) JM340 ½ Size 90mm (4 ¼ )* mm internal diameter (ID) and JM389 JM341 ½ Size 120mm (5 ½ )* mm length triple lumen devices with stainless JM342 ½ Size 135mm (6 )* steel lumens that are 1.2 mm ID and 275 mm length JM020 JM021 Extra Long Mini 73mm (3 )** mm ID and 310 mm length JM174 JM188 Mini 67mm (2 ⅝ )** mm ID and 317 mm length * The validation chamber load consisted of one container containing a basket and basket lid, mat, accessories, 12 lumens, and metal and non-metal medical devices **The validation chamber load consisted of two containers containing a basket and basket lid, mat, accessories, and metal and non-metal medical devices for a total chamber load weight of lbs. Each container held six (6) lumens for a total of 12 total lumens per load. Page 1 of 6

2 V-PRO 60 Sterilizer Non Lumen Cycle Lid Bottom Description Total loaded container weight (lbs) Intended Container Load JM440 Full Size 90mm (4 ¼ )* 20.0 JM489 JM441 Full Size 120mm (5 ½ )* 20.0 JM442 Full Size 135mm (6 )* 20.0 JM740 ¾ Size 90mm (4 ¼ )* JM789 JM741 ¾ Size 120mm (5 ½ )* Non-lumened devices including devices JM742 ¾ Size 135mm (6 )* with stainless steel or titanium diffusionrestricted spaces such as the hinged JM340 ½ Size 90mm (4 ¼ )* portion of forceps and scissors. JM389 JM341 ½ Size 120mm (5 ½ )* JM342 ½ Size 135mm (6 )* JM020 JM021 Extra Long Mini 73mm (3 )** 7.64 JM174 JM188 Mini 67mm (2 ⅝ )** 7.64 * The validation chamber load consisted of one container with a basket and basket lid, mat, accessories, and metal and non-metal medical devices **The validation chamber load consisted of two containers with a basket and basket lid, mat, accessories, and metal and non-metal medical devices for a total chamber load weight of lbs. V-PRO 60 Sterilizer Flexible Cycle Lid Bottom Description* JM489 JM789 JM389 Total loaded container weight (lbs) Intended Container Load JM440 Full Size 90mm (4 ¼ ) One flexible surgical endoscope or bronchoscope with a light cord (if not JM441 Full Size 120mm (5 ½ ) integral to the endoscope) and mat JM442 Full Size 135mm (6 ) without any additional load. The flexible JM740 ¾ Size 90mm (4 ¼ ) endoscopes may contain: JM741 ¾ Size 120mm (5 ½ ) single or dual lumen devices with lumens that are 1 mm ID and 990 JM742 ¾ Size 135mm (6 ) mm length JM340 ½ Size 90mm (4 ¼ ) JM341 ½ Size 120mm (5 ½ ) JM342 ½ Size 135mm (6 ) * The validation chamber load consisted of one container with a basket and lid, mat, accessories, three (3) 1 x 1000mm lumens, one flexible endoscope, and one light cable. V-PRO 60 Sterilizer Compatible SterilContainer S Accessories Accessories V-PRO 60 Stainless Steel baskets, basket lids, and dividers Instrument Organization System (Silicone and Stainless Steel racks, brackets, holders, and clamps) Silicone mats Stainless Steel racks, trays, holders, clamps, brackets, and platforms NOTE: The SterilContainer S bottoms and lids begin with a JM part number prefix. Do not use bottoms or lids that begin with a JN or JK prefix in V-PRO Sterilization Systems. Page 2 of 6

3 Inspection Prior to Use: Inspect the container system and accessories (bottom, lid, basket, instrument organization, etc.) prior to use. Inspection to include but not limited to: 1. Container system lid and bottom should mate adequately 2. Container system lid gasket should be secure in lid and free from cracking 3. Container system lid and bottom retention plates and silicone gaskets should be free from cracking or damage 4. Container system aluminum lid and perforated bottom filter retention posts should be secure 5. Container system should be free from visible corrosion If any of the above conditions are not satisfied, DO NOT USE. Remove product from service after adequate decontamination and contact Aesculap. Decontamination and Cleaning: Always wear appropriate personal protective equipment per the healthcare facility s policy when cleaning the SterilContainer S. Pre-Cleaning Preparation: 1. Remove the lid from the container system bottom 2. Remove the basket and any instruments from the container 3. Remove the container system lid and bottom filter retention plate(s) and discard the disposable filter(s) 4. Remove all single use container system accessories, such as indicator cards and tamper-evident locks Recommended Cleaners: Use only sodium carbonate-free, ph neutral (7) detergents to clean effectively and without causing damage to the SterilContainer S containers. If in doubt, contact the detergent manufacturer or supplier to determine suitability for use in cleaning the non-anodized aluminum and stainless steel SterilContainer S products. CAUTION: Do not use abrasive cleaners, metal brushes or abrasive cleaning pads. Use of abrasive products can cause permanent damage to SterilContainer S surfaces. Use of abrasive cleaners or pads will result in warranty exclusion. Manual Cleaning: 1. Clean container system components under water with a soft sponge and ph neutral detergent (see Recommended Cleaners section) until all visible debris has been removed from the surfaces. 2. Inspect container system components to insure all debris has been removed. Repeat step 1 as many times as necessary until no visible debris remains. 3. Rinse thoroughly to remove all detergent residue. Residual detergents can affect the surface of the container system. 4. To remove sterilization adhesive tape residue, use Aesculap-Eloxal Cleaner (Catalog number JG601). This is a non-abrasive cleaner. Apply the cream with a soft dry cloth and rub to polish the surface. Thoroughly rinse the container system under running water to remove all residual cleaning cream. 5. Thoroughly dry the container system and all components with a soft, lint-free, dry cloth. Page 3 of 6

4 Mechanical Cleaning: 1. Place the container bottom in the washer with the inside surface facing down to avoid water collection. 2. Fold the handles towards the inside of the lid. Place the lid with the inside surface facing down to avoid water collection. 3. Retention plates should be placed away from the direct force of pressurized washer jets to avoid damage during the washing cycle. 4. Thoroughly dry the container system and all components with a soft, lint-free, dry cloth. Pre-Assembly Inspection and Preparation: Inspect the container system and accessories (bottom, lid, basket, instrument organization, etc.) prior to use. Inspection to include but not limited to: 1. Container system lid and bottom should mate adequately 2. Container system lid gasket should be secure in lid and free from cracking 3. Container system lid and bottom retention plates and silicone gaskets should be free from cracking or damage 4. Container system lid and perforated bottom filter retention posts should be secure If any of the above conditions are not satisfied, DO NOT USE. Remove product from service after adequate decontamination and contact Aesculap. Filter Assembly: 1. Place one Aesculap filter over each perforated section on the inside of the SterilContainer S lid and bottom. 2. Secure each filter with the filter retention plate. CAUTION: Aesculap disposable filters are designed for one-time use only and must be discarded after each processing cycle. CAUTION: Only Polypropylene filters, Aesculap part numbers MD344 and MD355, should be used in V- PRO Sterilization Systems. NOTE: Only Aesculap filters have been validated with the SterilContainer S. Container System Assembly: 1. Place clean and dry instruments into the best suited tray or basket(s) 2. Place tray or basket(s) into appropriate Aesculap container system 3. Place assembled lid onto the container system bottom, aligning handles on bottom with latches on lid. 4. Close both locking latches on the container system lid. CAUTION: Do not exceed the validated chamber loads listed in the Indications for Use statement on the first pages of this booklet. NOTE: Leave one inch of free space between the instruments and the rim of the container bottom for effective processing. Basket handles may encroach into this clearance space as long as they do not interfere with the lid s filter retention plate or lid closure. Processing Supplies: 1. Select an indicator card that has been FDA cleared for use in the V-PRO 60 Sterilizer and applicable to the facility s processing flow. Insert into the holding bracket on the outside of the container system. Page 4 of 6

5 2. Insert a tamper-evident seal (US900) into the locking channel on each end and secure and lock the seals. Process Indicators: Process Indicators on indicator cards are External Chemical Indicators (CI), Class 1 Process Indicators. The indicator will turn a different color to indicate that the container system has been exposed to the sterilization process and to distinguish between processed and unprocessed container systems. These indicators only show that the container has been exposed to the sterilant and are not to be used to determine if the contents of the container are sterile. For routine load release, one Internal Chemical Indicator (Class 3 or above) should be placed in the center of each tray or basket or in the most challenging location to sterilant penetration depending on the organization, density and configuration of the instrument sets, as determined by the user. NOTE: Use of internal and external indicators should be in accordance with in-house protocol, determined by the user. Loading the Sterilizer: 1. The SterilContainer S should be placed flat on the shelf and should not touch the walls of the V- PRO 60 chamber. 2. The SterilContainer S should not be stacked in the V-PRO 60 chamber. Processing Recommendations: Run loaded sterilizer according to time and temperature recommended by the sterilizer manufacturer. CAUTION: For the V-PRO 60 sterilizer, only use Aesculap V-PRO Compatible SterilContainer S bottoms and lids. Do not use other non-v-pro compatible, Aesculap SterilContainer bottom and lids. NOTE: Consult with the manufacturer of the sterilizer for specific recommendations. Complex devices such as instruments with lumens should be sterilized in accordance with the instrument manufacturer s instructions. CAUTION: Wet filters or visible moisture within a load may compromise the sterile barrier and should not be considered sterile when removed from the sterilizer. Summary of testing: Sterilization performance studies were conducted for the Sterilcontainer S, in the V-PRO 60 Sterilizer with a total loaded container weight as listed in the indications for use statement. That weight includes baskets, instruments, silicon mats and Instrument Organization System components. The SterilContainer S successfully completed sterilization efficacy studies in the V-PRO 60 Sterilizer. The SterilContainer S successfully completed event related validation testing. Following sterilization, the SterilContainer S was placed in a Sterile Processing Department (SPD) test environment and handled on a weekly basis to simulate actual usage. After the test period of 180 days, the SterilContainer S was aseptically opened and contents were evaluated for sterility. The result was since an event did not occur; the SterilContainer S maintained sterility of the contents. Page 5 of 6

6 Aseptic Presentation: Hospital procedures and AAMI guidelines should always be followed when using and presenting the SterilContainer S. The following are a set of suggested steps for an aseptic presentation of a processed sterile container. 1. Non-scrubbed person positions container on a separate dry flat surface at or slightly above the level of the sterile field. 2. Non-scrubbed person inspects physical integrity of the closed container system to assure seals are in place. 3. Non-scrubbed person inspects the exterior chemical indicator(s). 4. Non-scrubbed person breaks and removes the locks. 5. Non-scrubbed person opens the latch and removes the lid in one single step, making sure that the container edge/bottom is not contaminated. 6. Non-scrubbed person checks the integrity of the filter(s) by removing the filter retention plate and examining. 7. Non-scrubbed person replaces the retention plate after inspecting the filter. 8. Scrubbed person removes the sterile contents inside by grasping both handles using appropriate aseptic technique, lifting basket and contents out, and placing basket and contents on a sterile surface. 9. Non-scrubbed person checks the filter(s) on the bottom if a perforated bottom container is used. Manufactured by Aesculap AG, Tuttlingen, Germany for: Aesculap, Inc Corporate Parkway Center Valley, PA USA Product and Service Contact Information: Aesculap, Inc. Attn: Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood, MO Aesculap Repair Hotline: Phone: Fax: SOP AIC Rev /15 Page 6 of 6