Instructions

Sterilization Trays

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0.0 Important general instructions for use

Ensure this product is only used as intended and described in this instruction manual, by adequately trained and qualified personnel and that maintenance and repair are completed as described in this instruction manual. Use this product only with the combinations and with the accessories and spare parts listed in this instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for this use and if the performance and safety requirements are met. Reprocess the products before every application and before returning them for repairs as required by the instruction manual in order to protect the patient, user, or third parties. Subject to technical changes! Due to continuous development of our products, illustration and technical data may deviate slightly from the data in this manual. Caution! Federal law restricts this device to sale by or on the order of a physician or dentist.

Richard Wolf Medical Instruments Corporation • 353 Corporate Woods Parkway • Vernon Hills • IL 60061-3110 Phone: 847-913-1113 • www.richardwolfusa.com • Customer Service: 800-323-WOLF (9653)

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0.0 Important general instructions for use .................................................................... 2 1.0 Intended Use ........................................................................................................... 4 2.0 Indications and field of Use .................................................................................... 4 3.0 Contraindications .................................................................................................... 4 4.0 Combinations .......................................................................................................... 5 5.0 Illustration (Examples)............................................................................................ 5

5.1 Technical data and order data ............................................................................. 6 5.1.1 Aluminum Trays, anodized finish............................................................... 6 5.1.2 Ultem/Radel Resin (Plastic) Trays............................................................ 10 5.1.3 Stainless Steel Trays, passivated finish .................................................... 12

6.0 Use ........................................................................................................................ 12 7.0 Checks after sterilization and prior to use............................................................. 13 8.0 Processing instructions.......................................................................................... 15 9.0 Disposal of product, packaging material and accessories ..................................... 16 10.0 Warranty and Customer Service ........................................................................... 17

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1.0 Intended Use Richard Wolf sterilization trays are intended to serve as packaging for instruments and other medical devices before, during, and after sterilization of the instruments and devices. Richard Wolf sterilization trays are intended to protect, organize and provide a transport vehicle to and from the sterile field.

2.0 Indications and Field of Use For assembly, organization and security of surgical instrumentation and medical devices, primarily for Richard Wolf surgical instrumentation and medical devices. Richard Wolf surgical instrumentation and medical devices include but are not limited to stainless steel instruments, flexible endoscopes, rigid endoscopes, and motorized hand-held medical devices. Intended to be used with the accompanying lid to the sterilization tray. Preparation and sterilization should only be carried out by trained personnel. Always use hospital’s policy concerning shelf life for items sterilized in-house.

3.0 Contraindications Sterilization trays that have a specific intended use have been validated for a specific sterilization method to match the intended Richard Wolf surgical instrumentation and medical devices for that tray. If other instrumentation and medical devices are added to the tray or to the sterilizer, the recommended parameters may not be valid and new cycle parameters may need to be validated by the user. Always refer to the manufacturer’s Instructions for Use when determining the use and sterilization parameters of a sterilization tray. Do not stack wrapped trays in a sterilizer. Stacking wrapped sterilizer trays may impede the sterilization process and drying cycle. Do not overload the tray with more instruments than its intended use. Too many instruments or medical devices could impede the sterilization process and drying times. Always handle and place wrapped sterilization tray with the lid facing up. The tray is not intended to be placed or handled on its side or upside down during sterilization, transport or storage. Always follow the manufacturer’s Instructions for Use for correct sterilization cycles and dry time for surgical instrumentation and medical devices that are contained within the sterilization tray. 890-09.08-0316 USA/ ECO 16-0041 Page 4 of 18

None of the sterilization trays are intended for gravity displacement sterilization. Not intended as a cleaning basket that is used in a washer/disinfector. For best cleaning results for the instruments, place instruments in a basket intended for use in a washer / disinfector. Not to be used as an immediate use sterilization (“flash”) tray. Do not use the tray if it is damaged or broken. Return any damaged or broken trays to Richard Wolf Medical Instruments, Corp in Vernon Hills, IL for review and possible repair. Always thoroughly disinfect the tray before sending the tray for evaluation.

4.0 Combinations The sterilization trays are intended to be used with an FDA-approved sterilization wrap. The sterilization wrap aids in air movement during sterilization and maintains a sterile barrier for the tray and when completed.

5.0 Illustration (Examples)

1. Lid with handles

2. Locking Mechanism

3. Tray bottom with instrument brackets

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5.1 Technical data and order data Products can be utilized according to their intended use. For the general overview, please refer to the latest catalog sheets and brochures or contact Richard Wolf Medical Instruments customer service or your Richard Wolf sales representative.

5.1.1 Aluminum Trays, anodized finish

Outer Dimensions

Illustration Catalog Number

Suggested Uses

1 tier 17.2”L x 17.5”W x 5.2”H

8585.026 Martin Arm Retractor

1 tier 9.9”L x 8.9”W x 2.9”H

8585.101 Camera Head

2 tier, 2 utility boxes 21.3” L x 10”W x 4.1”H

880100000 Morse Power Plus Tray; all Morce components & instruments

1 tier, 1 utility box 22.8”L x 11.1”W x 5.3”H

88090.0007 Rhizotomy instruments.

2 tier, 1 utility box 22.8”L x 11.1”W x 5.3”H

8585.025M Mediastinoscope and instruments; w/custom brackets

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Outer Dimensions

Illustration Catalog Number

Suggested Uses

1 tier 10.6”L x 5”W x 1.8”H

8585.091M Fascial Closure instruments

1 tier, 1 utility box 26.8”L x 11.1”W x 3.8”H

8585.027 Universal tray, longer instruments & endoscopes.

1 tier, 1 utility box 22.8”L x 11.1”W x 3.8”H

8585.023 Peds cysto rigid scopes, offset scopes and instruments. May add bracket 8585.750 for offset rigid scopes.

2 tier, 2 utility boxes 22.8”L x 11.1”W x 5.3”H

8585.025 Universal tray, w/universal brackets

2 tier 19.9”L x 8.9”W x 3.9”H

8585.071 Operating laparoscope, Piranha scope (add cat #), nephroscope

1 tier, 1 insert rack. 19.70”L x 8.73”W x 4.40”H. Deep finger mat and two scope brackets in tray base.

8585010 Laparoscopy Tray. Insert rack for laparoscopy instruments that are either 3, 5 or 10mm in diameter. light cord, power connecting cable and 1 – 2 rigid laparoscopes, 32cm in length.

1 tier, 1 insert rack. 24.35”L x 8.73”W x 4.40”H. Deep finger mat in the

8585012 Laparoscopy Tray. Insert rack for long laparoscopy instruments that are either 3, 5 or 10mm in diameter. Light cord, power

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Outer Dimensions

Illustration Catalog Number

Suggested Uses

tray base. Two scope brackets in base. Aluminum base, Radel plastic lid.

connecting cable and 1 – 2 rigid laparoscopes, 32 – 44cm in length.

2 tier 19.9”L x 8.9”W x 3.9”H

8585.072 Universal tray. Peds cysto, basic ENT instruments and rigid straight scopes.

1 tier 21.9”L x 10.2”W x 2.8”H

8585.073 Universal tray. Adult or peds cysto, GU or GYN resection; ENT or Arthroscopy scope/instruments.

1 tier 16.1”L x 10.7”W x 3”H

8585.145 Universal tray. Adult cysto.

1 tier 24.3”L x 6.4”W x 3.5”H

880900015 Universal tray. 1 long semi-rigid ureteroscope, offset or straight eyepiece. May use with any off-set or straight eyepiece rigid endoscope. Light cable, limited # of instruments (3mm, 5mm or 10mm). May use with utility tray 880900016.

1 tier 12.3” L x 5.8” W x 1.6” H

880900016 Universal tray insert. May use with universal tray 880900015 for accessory items.

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Outer Dimensions

Illustration Catalog Number

Suggested Uses

2 tier. 20.4”L x 9.9”W x4.9”D Ultem end panels, aluminum body and lid.

8585030 Cystoscopy tray. Use for either adult or pediatric cystoscopy instruments, light cable and accessories.

2 tier. 20.4”L x 9.9”W x 3.3”D Ultem end panels, aluminum body and lid.

8585032 Urology Resection tray. Use for either adult or pediatric resection instruments, HF cable and accessories.

1 tier. 20.4” L x 9.9” W x 2.9” D Ultem end panels, aluminum body and lid.

8585038 Pediatric All-in-One tray. Use for pediatric scopes with integrated sheaths (offset or straight eyepiece), light cable, HF cable and electrical probe.

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Outer Dimensions

Illustration Catalog Number

Suggested Uses

3 tier, 1 utility box, 1 tray lid. 21.2”L x 10.4”W x 5.1”H.

88090001 Lumbar Spine tray. 2 spine rigid endoscopes lumbar spine instruments, light cord, accessories for spine scopes and instruments.

3 tier, 1 utility box, 1 tray lid. 21.2”L x 10.4”W x 4.6”H.

88090009 Stenosis Spine tray. 2 rigid stenosis spine endoscopes, stenosis instruments, light cord, accessories for stenosis scopes and instruments.

5.1.2 Radel or Ultem Resin (Plastic) Trays

Dimensions Illustration Catalog Number

Suggested Use

1 tier 17”L x 3.2”W x 1.6H

8570.005 Dual 5mm, 32 cm length rigid scopes, straight eyepiece.

1 tier 17”L x 3.2”W x 1.6”H

8570.010 Dual 10mm, 32 cm length rigid scopes, straight eyepiece.

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Dimensions Illustration Catalog Number

Suggested Use

1 tier. 12” L x 3.2”W x 1.6” H

(picture not available) 8570.012 Single 1.9mm – 5mm short rigid endoscope, straight eyepiece.

1 tier 17”L x 3.2”W x 1.6”H

8570.017 Single 5mm – 10mm, 32 cm length, rigid single scope, straight eyepiece

1 tier 26.2”L x 4.5”W x 3.1”H

8570.019 Single long scope, 1 semi-rigid ureteroscope with straight eyepiece, 330mm or 440mm rigid scopes with straight eyepiece.

1 tier 19.8”L x 9”W x 3”H

8570.040 Single off-set hysteroscopy scopes & limited instruments, light cable

1 tier 19.8” L x 9” W x 1.8” H

8570.027 Straight eyepiece hysteroscope, limited instruments, light cable.

1 tier 15.1”L x 10.1”W x 2.23”H

880900012 HD camera with cord. Will hold 1 each of a 1-chip, or 3-chip or Pendual camera. 1 each camera coupler.

1 tier 21.3”L x 10”W x 3”H

8585035 Digital flexible endoscope. BOA Vision, Cobra Vision, or digital flexible cystoscope. With two small-part compartments for adapters/accessories.

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5.1.3 Stainless Steel Trays, passivated finish

Dimensions Illustration Catalog Number

Suggested Use

1 tier, 1 utility box 22.5”L x 10.5”W x 2.9”H Ultem end panels, stainless steel body and lid.

85850302 Flexible fiberscope. Combination or single pkg: flexible ureterorenoscope, flexible cystoscope, flexible ENT scope, lightcord and scope accessories.

1 tier 18.5”L x 7.8”W x 5.5”H

(picture not available) 38043012 May be used to process, sterilize TEM scope. TEM tray may be used as a cleaning basket for the TEM scope.

1 tier 18.6”L x 5.2”W x 2.9”H

(picture not available) 38044411 May use to process, sterilize spine discoscopes. Tray may be used to process, sterilize discoscopes. May be used for cleaning basket for discoscope.

6.0 Use Suggested use of the sterilization trays is based on size of the instrument and fit to the brackets within the tray. Each tray has been carefully designed to ensure the trays are not overloaded and provide the optimum safety for the instrument. For special designated trays, brackets and in some cases, specific instrument silhouettes are incorporated inside of the tray to ensure the instruments are positioned in such a way to maximize sterilization and protection of the instruments and medical device.

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Sterilization trays may be used to contain and transport soiled instruments following a surgical procedure. The tray with soiled instruments must be contained during transport to avoid cross-contamination during transportation.

Always clean and disinfect the sterilization tray before its initial use and then after each time the tray has been used following the processing instructions outlined in this manual. Do not use any abrasive cleaners or pads, metal or wire brushes, or solvents when cleaning the trays. Do not use the wrapped sterilization tray before it has been properly cooled. Using a moist, warm tray has the potential for condensation and contamination from wicking. Segregate the warm, moist sterilized trays until they have been completely cooled and dry to the touch.

Always refer to the manufacturer’s Instructions for Use (IFU) of the specific instruments to ensure the instruments and medical devices have been thoroughly cleaned before placing into the sterilization tray.

Always refer to the manufacturer’s Instructions for Use (IFU) of the specific instruments to ensure the correct sterilization methods are being used.

Place a chemical indicator in every level of the tray, including a utility box within a tray, and in the most challenged area of the tray. Ensure the chemical indicator is appropriate for the indicated sterilization method (steam, EO, hydrogen peroxide). Follow the hospital policy regarding inserting a paper tray list or any other instructional inserts inside of the tray prior to wrapping and sterilization.

Once the instruments and chemical indicators have been securely placed in the tray, seat the lid onto the tray and secure with the locking latches.

Wrap with appropriate size and weight sterilization wrap, secure with the sterilization tape for the indicated sterilization method (steam, EO, hydrogen peroxide). If needed, corner protectors or tray liners that have been validated for the indicated sterilization method may be used on the outside of the tray corners or the bottom of the tray prior to wrapping in sterilization wrap.

7.0 Checks after sterilization and prior to use

Prior to unwrapping the sterilized wrapped tray, Operating Room personnel should inspect the outside of the wrap to ensure the wrap is intact and has no tears or holes. Ensure the sterilization tape is secure and has changed colors to indicate it has been exposed to a sterilization cycle.

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1. After unwrapping the sterilization tray, Operating Room personnel checks to

ensure the chemical indicators have turned the appropriate color to indicate each level of the tray has been exposed to a sterilization process. Hold the sterilization wrap to the light to ensure there are no holes or rips in the wrap.

2. Functional checks, Central Sterile Supply Department (CSSD) and Operating

Room. Ensure the tray is not damaged on the corners, lid, and lip of tray. Ensure the lid is not bent or dented and the latches are in working order. Ensure the handles are not broken. Ensure the brackets are not broken or bent, ripped or displaced.

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8.0 Processing instructions CAUTIONS! Aluminum-based sterilization trays are damaged by alkaline (pH> 7)

detergents and solutions. Wire brushes may damage the finish of any sterilization trays and are not be used when cleaning the sterilization trays.

Limitations on reprocessing:

Repeated processing has little effect on these sterilization trays. End of life is normally determined by wear and damage due to use.

INSTRUCTIONS Preparation at point of use:

Remove excess soil with moist towel or cloth. Clean used sterilization tray and instruments as soon as practically possible following use.

Containment, transport:

Place, secure tray with or without used instruments into an enclosed transport bin or enclosed case cart to prevent cross-contamination during transport. Moisten instruments with either a wet towel or an FDA-approved pH-neutral pre-clean or pre-transport wetting spray to avoid debris from drying to the instrument.

Preparation for cleaning:

Separate all used surgical instruments from the used sterilization tray, no other disassembly required. Discard any remaining disposable trash from the tray (indicators, used towels, paper products, etc). May use a pre-treat spray for grossly soiled sterilization trays.

Cleaning, Manual

Rinse any pre-clean spray and debris from sterilization tray using tepid water (>350 C/950 F). Immerse in enzymatic detergent solution for at least 3 minutes and wash using a soft, lint-free cloth. Always wash metal trays with the grain of the metal. When completed, rinse with tepid, deminerilized water for at least 20 seconds. Dry thoroughly before using.

Disinfection after manual cleaning

May use disinfection solution appropriate for mid-level disinfection. Use according to disinfectant manufacturer’s label instructions.

Ultrasonic Do not use an ultrasonic unit to clean the sterilization trays.

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Cleaning, automated

Consult the washer manufacturer’s Instructions for Use when cleaning the sterilization trays in an automated machine. Ensure the machine is intended to clean sterilization trays. Use the cycle specific to sterilization trays if the automated machine is equipped as such. Ensure the detergent used in the machine is pH neutral. Final rinse for established time/temperature may be used to effect thermal disinfection.

Inspection and functional testing:

No lubrication is required for sterilization trays. Check the locking mechanisms on the tray. Inspect for dents in the lid or the sides of the lid. Check the tray bottom for dents on the lip and corners of the tray. Check the brackets for wear, dents and if ripped or missing. Check that instruments fit into the brackets as intended for proper fit and is not damaging the instrument(s).

Packaging In sets only: Assemble instruments according to intended use and hospital’s tray list. Ensure the trays do not exceed 25 lbs. Wrap the trays according to the hospital’s protocol and established AAMI recommended practices *. Always follow the manufacturer’s Instructions for Use for proper assembly/disassembly of the instruments for sterilization.

Sterilization Sterilization modalities are according to the manufacturer’s Instructions for Use of the specific instruments contained within the sterilization tray. All generic trays listed in this manual are compatible with pre-vac steam, EO, Sterrad and V-PRO sterilization. Trays that contain specific instruments are compatible with the sterilization modalities recommended for those instruments. Please see the instrument-specific IFU for complete sterilization recommendations.

Storage Store in restricted area with approximately 240 C/750F, at least 4 air exchanges per hour and a relative humidity that does exceed 70%, as per AAMI recommendations, ST79

*The 8585030 Cystoscopy Tray, 8585032 Urology Resection Tray, and 8585038 Pediatric All-in-One Tray are also validated for steam sterilization in Aesculap closed containers.

9.0 Disposal of product, packaging material and accessories Observe the regulations and laws valid for your local, state or federal government when discarding used sterilization trays potentially contaminated with medical waste. 890-09.08-0316 USA/ ECO 16-0041 Page 16 of 18

10.0 Warranty and Customer Service Richard Wolf guarantees our instruments to be free from any defects in materials and workmanship under normal use and service for one year. Richard Wolf general terms and conditions may be found on the back of our invoice. Parts delivered separately by Richard Wolf are subject to all of the same general terms and conditions for our products, including the limitations of warranty and liability. All products should be returned to Richard Wolf for any necessary or desired repair or part replacement. No product repair or part replacement should be done other than by Richard Wolf unless the care and instruction manual or other written information indicates that repair or part replacement is authorized. If authorized, parts must be replaced only by parts supplied or specified by Richard Wolf, and product repair and part replacement must be done in strict conformance with Richard Wolf specifications and instructions for repair and part replacement, including post replacement testing and recalibration. Failure to follow this requirement in any way can be dangerous to you, your personnel and your patients and voids the warranty for the product repaired or the product in which the part was replaced and if the part was supplied by Richard Wolf, for that part. Delivery by Richard Wolf of technical documents such as circuit or other design diagrams does not constitute authorization for product repair or part replacement. Richard Wolf instruments and other products should never be modified or altered under any circumstances. Contact Richard Wolf if you have any question (1) whether replacement of a part or a repair is authorized by Richard Wolf, or (2) whether you have complete instructions and specifications for part replacement or repair. These instructions do not attempt to cover all details or variations in equipment, or to provide for every possible contingency to be met in connection with installation, operation, or maintenance. Should further information be required or should problems arise which are not covered sufficiently for the purchaser’s purpose, the matter should be referred to Richard Wolf Medical Instruments Corporation. Our national sales and service offices, as well as our manufacturing facility, are located in Illinois. Trained manufacturer’s representatives are located throughout the U.S. to serve you. For any questions regarding these instruments, or to place an order, contact Richard Wolf customer service department at 847 – 913 – 1113 or 800 – 323 – WOLF (9653).

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INSTRUMENT ORDERING POLICY Richard Wolf reserves the right to make substitutions, if necessary, without prior notice. REPAIR POLICY When returning your instrument for repair, we suggest that you prevent shipping damage to the instrument by reusing the box that it was originally shipped in. Richard Wolf also recommends that the instrument be insured for an amount to cover the cost of replacement.

IMPORTANT For general safety and health reasons, Richard Wolf requires that you clean and sterilize all instruments before returning them for repair. If instruments are received in an unsanitary condition, Richard Wolf will clean and sterilize each instrument and add a $100.00 cleaning charge for each instrument that required cleaning.

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