Sterilization Tray for Flexible Cystoscopes/Ureteroscopes Reprocessing Guide

Contents Introduction... 2 Intended Use of Sterilization Trays... 2 Warnings... 3 Cautions... 3 Instructions... 4 Sterilization Tray Setup... 10 References... 11

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Introduction This reprocessing guide provides instructions for the proper cleaning and sterilization of the following sterilization trays. For tray/device configuration, see the “Sterilization Tray Setup” section of this guide. 0233-032-113 Sterilization Tray for Flexible Cystoscopes/Ureteroscopes This sterilization tray is intended for use only with one of the endoscopes listed below. Compatible Parts

Description

0502-110-111

IDEAL EYES® HD URT-7000S Flexible Video Ureteroscope (standard articulation)

0502-110-112

IDEAL EYES® HD URT-7000Si Flexible Video Ureteroscope (intuitive articulation)

0502-110-113

IDEAL EYES® HD CST-5000S Flexible Video Cystoscope/Hysteroscope (standard articulation)

0502-110-114

IDEAL EYES® HD CST-5000iS Flexible Video Cystoscope/Hysteroscope (intuitive articulation)

0503-888-020

CST-4000S Flexible Fiberoptic Cystoscope/Hysteroscope (standard articulation)

0503-888-021

CST-4000iS Flexible Fiberoptic Cystoscope/Hysteroscope (intuitive articulation)

These reprocessing instructions are provided in accordance with ISO 17664, AAMI TIR12, AAMI ST79, and AAMI ST81. While they have been validated by Stryker as being capable of preparing the device 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. Stryker recommends users observe these standards when reprocessing medical devices.

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 silicone device holders that secure devices during the sterilization process. Some models feature stacking internal trays to allow the segregation of devices. 2

Warnings • These instructions are validated only for sterilization of the trays identified herein. Using combinations or parameters not described in this manual may result in incomplete sterilization. • These instructions do not replace the cleaning and sterilization instructions provided with individual devices. • Wear appropriate protective equipment (gloves, eye protection, etc.) when reprocessing any medical device. • The tray must be cleaned prior to sterilization, or incomplete sterilization may 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. • The endoscope video cable must be arranged inside the tray as shown in the “Sterilization Tray Setup” section. Incomplete sterilization may result if the cable is arranged in any other configuration.

Cautions • 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 Reprocessing

• Proper processing has a minimal effect on this tray. End of life is normally determined by wear and damage due to use. • Do not leave the tray in solutions longer than necessary. This may accelerate normal product aging. • Damage incurred by improper processing will not be covered by the warranty.

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Instructions

Instructions apply to the sterilization tray only. For instructions on how to reprocess the devices, consult their respective instructions for use.

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Use of Latches

• To open the sterilization tray latch, push in on the release lever (as indicated in the diagram below), then pull out and down. • To close the sterilization tray latch, push in on the release lever (as indicated in the diagram below), then return the latch to the up (locked) position. Once in the up position, push in on the center of the latch to ensure it is fully locked. • Before lifting the tray assembly, verify that both latches connecting the lid to the tray are secure.

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 Transportation

• Reprocess the tray as soon as reasonably practical following use. Note: A 30 minute wait time was used during cleaning validation.

Preparation for Manual Cleaning

1 2 3

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Disassemble the tray into its individual components: the base and the lid. Wipe excess soil from the tray using a dry, clean cloth. Prepare an enzymatic detergent solution1 according to the manufacturer’s recommendations. Immerse the tray in the solution, ensuring the solution contacts all inner and outer surfaces of the tray. Soak the tray for a minimum of 15 minutes.

Cleaning was validated using ENZOL® at 1 oz/gal. at 37 °C.

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Manual Cleaning

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Brush • Thoroughly brush the tray with a soft-bristled brush, focusing on mated and rough surfaces. • Using a pipe cleaner and syringe, brush and flush the hard-to-reach areas of the tray. • Brush around all movable parts while moving them through their extreme open and closed positions.

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Rinse • Remove the tray from the solution and rinse it with water2 at ambient temperature until all visible detergent residue is removed. • After all detergent residue has been removed, continue to rinse for a minimum of 30 seconds. • Drain any excess water from the tray and dry it using a clean, soft cloth. Filtered pressurized air can be used to assist in drying.

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Soak • Prepare a non-enzymatic detergent solution3 according to the manufacturer’s recommendations. • Immerse the tray in the solution, ensuring the solution contacts all inner and outer surfaces of the tray. Use a syringe to inject any mated surfaces with at least 50 mL of the solution. • Soak the tray for a minimum of 15 minutes.

2

Cleaning was validated using reverse osmosis/deionized water. 3

Cleaning was validated using Prolystica® 2x Neutral Detergent at 1/8 oz/gal. at 37 °C.

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Automated Cleaning

4

Cleaning was validated using reverse osmosis/deionized water.

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4

Brush • Thoroughly brush the exterior of the tray using a soft-bristled brush. • Use a syringe to inject any mated surfaces with the prepared solution a minimum of five times. • Using a pipe cleaner and syringe, brush and flush the hard-to-reach areas of the tray. • Brush around all movable parts while moving them through their extreme open and closed positions.

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Rinse and Dry • Remove the tray from the solution and rinse it with water at at ambient temperature until all visible detergent residue is removed. • Flush all lumens, crevices, and mated surfaces at least five times. • After all detergent residue has been removed, continue to rinse for a minimum of 30 seconds.

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Dry and Inspect • Drain any excess water from the tray and dry it using a clean, soft cloth. Filtered pressurized air can be used to assist in drying. • Visually inspect the tray for cleanliness, paying close attention to hard-to-reach areas. If visible soil remains, repeat cleaning.

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Rinse • Disassemble the tray into its individual components: the base and the lid. • Rinse the tray with treated water4 at ambient temperature until there is no visible soil. Use a syringe to assist in rinsing.

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Recirculation Time

Water Temperature

Detergent type and concentration

Pre Wash

2 min.

Cold tap water

-

Enzyme Wash

2 min.

Hot tap water

Enzymatic detergent5

Wash 1

2 min.

Set point 60 °C (140 °F)

Non enzymatic detergent6

Rinse 1

2 min.

Heated 60 °C (140 °F)

-

Dry Phase

7 min.

Drying Temperature

-

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Cleaning was validated using ENZOL at 1 oz/gal.

Dry and Inspect • Dry the tray using a clean soft cloth. Use filtered pressurized air (40 psi) to assist in drying. • Visually inspect the tray for cleanliness, paying close attention to hard-to-reach areas.

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Disinfect the tray in a disinfecting solution that has ≥ 2.4% glutaraldehyde as an active ingredient.7 Prepare the solution according to the manufacturer’s instructions. Immerse the tray in the disinfecting solution for a minimum time of 45 minutes at 25 °C. Thoroughly rinse the tray by fully immersing it in treated water.8 Agitate the tray and allow it to remain in contact with the water for a minimum of one minute. Repeat two additional times, using fresh treated water for each rinse. Dry the tray with a sterile, lint-free cloth immediately after rinsing. Filtered pressurized air can be used to assist in drying.9

Cleaning was validated using Prolystica 2x Neutral Detergent at 1/8 oz/gal.

Disinfection (optional)

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Disinfection was validated using CIDEX® Activated Dialdehyde Solution.

3

8

Disinfection was validated using PURW or reverse osmosis/ deionized (RO/DI) water. Drying was validated with filtered pressurized air at 40 psi.

115 °C (239 °F)

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6

9

Automated wash • Place the tray in the washer on an incline to facilitate drainage. • Program the washer using the settings below.

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Maintenance

• No routine maintenance is required for the sterilization tray.

Inspection and Testing

• Inspect the tray for dents and cracks. If a problem 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 procedures.

Packaging for Sterilization

• Double-wrap the tray unless otherwise noted in the sterilization method.10

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Sterilization was validated using Kimberly-Clark KC600 KIMGUARD® sterilization wrap.

Sterilization

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• Prepare the device and the sterilization tray as indicated in the “Sterilization Tray Setup” section that follows. • Warning: The endoscope video cable must be arranged inside the tray as shown in “Sterilization Tray Setup.” Incomplete sterilization may result if the cable is arranged in any other configuration. • For United States users: when sterilizing the endoscope and tray, use only sterilization wraps, biological indicators (optional), and chemical indicators (optional) that have been cleared by the FDA to use with the selected sterilization cycle. • Perform one of the sterilization options below.

Ethylene oxide (EO) • If using EO, sterilize the device inside the tray according to the following parameters. Preconditioning

Sterilization

Aeration

Temperature

55 °C (131 °F)

55 °C (131 °F)

51–59 °C (124–138 °F)

Relative Humidity

70%

70%

-

Vacuum Set Points

1.30 psia

-

-

-

725 mg/L (100% EO)

-

30 minutes

1 hour

12 hours

EO Concentration Time

Sterrad • If using Sterrad®, sterilize the device inside the tray using the Sterrad 100S, NX®, or 100NX® system. Follow the manufacturer’s instructions.

Storage

• To preserve sterility, remove devices from any standing solution that may have pooled in the tray during the sterilization process.

Additional Information

N/A

Manufacturer Contact

Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA 1-800-624-4422 U.S. Patents: www.stryker.com/patents

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Sterilization Tray Setup

Max. Weight Load (device and tray combined)

8.7 lb (4.0 kg) (value given is the heaviest combination of tray 0233032-113 and scope 0502-110-111)

Internal Stacking

No internal stacking is permitted with this tray.

External Stacking

Do not stack other trays or devices on or below this tray.

Accessories

There are no accessories available for use with this tray.

Device Distribution

• Place the scope in the tray as shown above. • Ensure the scope is properly secured in the tabs before moving the tray. • Arrange the video cable along the perimeter of the tray (as shown above) to allow for maximum sterilant exposure around all surfaces of the cable. Warning: Arranging the cable in a manner other than as shown above may result in incomplete sterilization.

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Chemical Indicator

Place the chemical indicator ( illustrated above.

) in the location

Biological Indicator

Place the biological indicator ( ) between a device and the silicone tab, as illustrated above.

References • ISO 17664-Sterilization of medical devices-Information to be provided by the manufacturer for the processing of resterilizable medical devices • ANSI/AAMI ST77-Containment devices for reusable medical device sterilization • ANSI/AAMI ST79-A comprehensive guide to steam sterilization and sterility assurance 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

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Produced for: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA 1-800-624-4422 U.S. Patents: www.stryker.com/patents Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: IDEAL EYES and the Stryker logo. All other trademarks are trademarks of their respective owners or holders.

2016/02