Small-Joint Rigid Instrument Sterilization Case User Guide

Contents Introduction... 2 Intended Use of Sterilization Cases... 3 Warnings... 3 Cautions. ... 4 Instructions... 4 Sterilization Case Setup... 11 References. ... 12

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Introduction This reprocessing guide provides instructions for the proper cleaning and sterilization of the following sterilization case. 233-032-130

Small-Joint Rigid Instrument Sterilization Case

This sterilization case is intended for use only with the devices listed below. For case/ device configuration, see the “Sterilization Case Setup” section of this guide.

Part Number

Desciption

233-070-001

Camelback Handle

275-023-027

2.7mm Scope Bridge

275-035-302

3.5mm Small Joint Cutter Cannula

With any 11 of the below instruments

Part Number

Desciption

233-071-001

2.0mm Angled Probe

233-071-002

1.5mm Straight Probe

233-071-003

2.0mm Straight Rasp

233-071-004

2.0mm Back Angled Rasp

233-071-005

2.0mm Up Angled Rasp

233-071-006

2.0mm Retrograde Knife

233-071-007

2.5mm Hook Knife

233-071-008

2.0mm Smillie Knife

233-071-011

2.0mm Serrated Straight Knife

233-071-013

1.5mm Straight Scalpel Knife

233-071-014

1.5mm Curved Scalpel Knife

With any two of the below instruments.

Part Number

Desciption

275-035-100

3.5mm Trocar

275-035-200

3.5mm Obturator

These reprocessing instructions are provided in accordance with ISO 17664, AAMI TIR 12, 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. 2

Intended Use of Sterilization Cases Sterilization cases are plastic and/or metal containers used to hold and protect surgical devices during the sterilization process. They consist of an interlocking case and lid, which are both perforated to allow the passage of sterilizing agent from outside the case to the devices placed inside. Sterilization cases typically feature a silicon finger mat or group of device holders that secure devices during the sterilization process. Some models feature stacking internal cases to allow the segregation of devices.

Warnings • These instructions are validated only for sterilization of the case 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 devices and the case must be cleaned prior to sterilization, or incomplete sterilization will result. • The sterilization case, 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 case and its components for visible damage, such as cracking or chipping, prior to use. Do not use the case if it is damaged.

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Cautions • Before lifting the case assembly, verify that the latches connecting the lid to the case are secure. • The case 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 case. End of life is normally determined by wear and damage due to use. • Do not cross-sterilize the case. Using multiple sterilization methods may significantly reduce the performance of the case. • Do not leave the case in solutions longer than necessary. This may accelerate normal product aging. • Damage incurred by improper processing will not be covered by the warranty.

Instructions

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

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Point of Use

• Wipe excess soil from the case using disposable paper towels. • If an automated cleaning method will be used, rinse the case in sterile distilled water immediately after use.

Containment and Transportation

• Reprocess the device/case within 30 minutes following use.

Preparation for Manual Cleaning

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2 3 4

Disassemble the case into its individual components: the base, lid, and (if applicable) silicon mat. Prepare an enzymatic detergent1 according to the manufacturer’s recommendations. Wipe the entire case with a clean cloth dipped in the detergent. Immerse the case in the detergent. Soak the case in the detergent for at least 15 minutes.

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Cleaning was validated using Enzol® at 1 oz/gal. at 35-40°C.

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Manual Cleaning

1

Brush • Thoroughly brush the exterior of the case with a soft-bristled brush, focusing on any mated or rough surfaces. • Using a pipe cleaner and syringe, brush and flush the hard-to-reach areas of the case. • Actuate the case, brushing any movable parts in their extreme open and closed positions.

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Rinse • Rinse the case 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 case and dry it using a clean cloth and pressurized air (40 psi). • Visually inspect the case for cleanliness, paying close attention to hard-to-reach areas. If visible soil remains, repeat steps 1 and 2.

3

Soak • Prepare a non-enzymatic detergent2 according to the manufacturer’s recommendations. • Fully immerse the case and inject any mated surfaces with at least 50mL of the detergent. • Soak the case for a minimum of 15 minutes.

2

Cleaning was validated using Renu-Klenz™ at ¼ oz/gal. at 35-40°C.

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Automated Cleaning

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4

Brush • Thoroughly brush the exterior of the case using a soft-bristled brush. • Inject the prepared detergent into any mated surfaces a minimum of five times. • Actuate the case, 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 case.

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Rinse • Thoroughly rinse the case 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 case and dry it with a clean cloth and pressurized air (40 psi). • Visually inspect the case for cleanliness, paying close attention to hard-to-reach areas.

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Rinse • Disassemble the case into its individual components: the base, lid, and (if applicable) silicon mat. • Rinse the case with RO/DI water at ambient temperature until there is no visible soil. Use a syringe to assist in rinsing. After all visible soil has been removed, continue to rinse for a minimum of 30 seconds. • Place the case in the washer on an incline to facilitate drainage.

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Automated wash • Program the washer using the following parameters:

Recirculation Time

Water Temperature

Detergent type and concentration

Pre Wash

2 min.

Cold tap water

-

Enzyme Wash

2 min.

Hot tap water

Enzymatic Detergent3

Wash 1

2 min.

Set point 60°C (140°F)

Non Enzymatic Detergent4

Rinse 1

2 min.

Heated 60°C (140°F)

-

Dry Phase

7 min.

Drying Temperature

-

115°C (239°F)

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Cleaning was validated using Enzol® at 1 oz/gal. at 35-40°C. 4 Cleaning was validated using Renu-Klenz™ at ¼ oz/gal. 3

Maintenance

Drying • Remove the case from the washer after the completion of the dry phase. • Dry the case using a clean soft cloth. Use filtered pressurized air (40 psi) to assist in drying. • Visually inspect the case for cleanliness, paying close attention to hard-to-reach areas. • No routine maintenance is required for the sterilization case.

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Inspection and Testing

• Inspect the case for dents and cracks. If a problem is observed or suspected, the case 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 Sterilization

Double-wrap the case unless otherwise noted below.

Sterilization

Warning: Disassemble all instruments (e.g. cannula and scope bridge) prior to sterilization; otherwise, non-sterile products may result. Warning: Place the stopcock of the devices (where applicable) in the open position prior to sterilization; otherwise, non-sterile products may result. Warning: Turn the thumbscrew on the camelback handle counterclockwise until the stop is reached prior to sterilization; otherwise, non-sterile products may result. • Prepare the device(s) and the sterilization case as indicated in the “Sterilization Case Setup” section below. • Sterilize the device(s) inside the case according to the parameters indicated below (Ethylene Oxide and Autoclave (Steam) only).

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Ethylene oxide (EtO) Preconditioning

Sterilization

Aeration

Temperature

55°C (131°F )

55°C (131°F )

51–59°C (119–138°F)

Relative Humidity

70%

70%

-

Vacuum Set Points

1.30 psia

-

-

EtO Concentration

-

600 mg/L 100% EtO

-

60 minutes

2 hours

12 hours

Gravity

Prevacuum

“Flash” Prevacuum

Wrapping

double

double

-

Temperature

132°C (270°F)

132°C (270°F)

132°C (270°F)

Time

30 minutes

5 minutes

5 minutes

Dry Time

45 minutes

30 minutes

-

Time

Autoclave (Steam)

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.

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Storage

Cases 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 Information

N/A

Manufacturer Contact

Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 +1.800.624.2244, +1.408.754.2000 www.stryker.com

Sterilization Case Setup Maximum Weight Load (devices and case combined)

1.52 kg (3.35 lbs)

Internal Stacking

No internal stacking is permitted with this case.

External Stacking

Do not stack other cases or devices on or below this case.

Accessories

There are no accessories available for use with this case.

Device Distribution

Devices should be placed in the case as illustrated below.

Chemical Indicator Place the chemical indicator ( ) in the bottom-right corner of the case as illustrated below. Biological Indicator Place the biological indicator ( tip as illustrated below.

) at any instrument

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References • ISO 17664-Sterilization of medical devices-Information to be provided by the manufacturer for the processing of resterilizable medical devices • ANSI/AAMI ST81-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

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목차 소개(Introduction)... 186 멸균 케이스 사용 목적(Intended Use of Sterilization Cases). ... 187 경고(Warnings)... 187 주의(Cautions). ... 188 지침(Instructions)... 188 멸균 케이스 설정(Sterilization Case Setup). ... 195 참고 문헌(References). ... 196

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Produced for Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA +1.800.624.4422 +1.408.754.2000 www.stryker.com European Representative Regulatory Manager, Stryker France ZAC Satolas Green Pusignan Ave. De Satolas Green 69881 MEYZIEU Cedex, France P10300 B 2010/05

Stryker® is a registered trademark of Stryker Corporation. ENZOL® Enzymatic Detergent is a registered trademark of Advanced Sterilization Products, Division of Ethicon Inc., a Johnson and Johnson company. Renu-Klenz™ is a trademark of STERIS corporation.