DORC Reusable Instruments Reprocessing Instructions

The DORC reusable instruments (including accessories) have been designed for ophthalmic surgical use. The following are reprocessing instructions for the reusable instrument provided. When additional device specific instructions are supplied with the device, please use the additional instructions in addition to this document. WARNINGS

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Limitations on reprocessing

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Cleaning: Manual

Process steps: 1. Remove the protection caps prior to cleaning and sterilization. 2. Immerse the instrument in a clean basin filled with fresh neutral pH cleaning solution for at least 5 minutes. Make sure lumens are completely filled with cleaning solution. 3. Carefully scrub all surfaces of the instrument, while it is immersed, using a soft cleaning brush. Clean until all visible soil is removed from the instrument. Warning: Never process phaco handpieces in an ultrasonic bath! For phaco handpieces continue with step 5. 4. Place the instrument on a silicone finger mat in an ultrasonic cleaner. The ultrasonic cleaner should be filled with fresh neutral pH cleaning solution. Start the ultrasonic cleaner per equipment instructions for at least 5 minutes at temperature setting as per cleaning solution instruction. 5. Place the instrument in deionized water for at least 2 minutes and make sure lumens are completely filled with deionized water. 6. Rinse the instrument under cold deionized running water for at least 15 seconds. Rotate the instrument while rinsing to expose all surfaces and cavities to the water. 7. All lumens must be rinsed with a syringe (10 ml) with deionized water at least 5 times. Instruments with a mechanical function (like forceps and scissors) should be operated at least 10 times under cold deionized running water. 8. If the last rinsing solution is not clear or if impurities are still visible on the products, repeat all 7 steps.

Disinfection:

A 10 minute 80°C (176°F) thermal disinfection before drying is recommended. Due to the potential for residual chemicals to remain on the instrument, a chemical disinfection is not recommeded. Note: Alternative time-temperature combinations resulting in at least an equal A0-value can be used.

New or repaired products are supplied in a non-sterile state and are not to be used without being cleaned and sterilized in accordance with these reprocessing instructions. The persons involved in medical device reprocessing must have the necessary expertise, to ensure orderly reprocessing and to prevent damage to the medical devices All reprocessing steps should be carried out in dedicated cleaning/disinfection zones, while taking account of occupational h ealth and safety regulations. Do not exceed 140°C (284°F). Repeated reprocessing has minimal effect on these instruments. End of life is normally determined by wear and damage due to use. DORC reusable instruments are high precision products that can contain delicate operating mechanisms and / or small lumen. Special care is required to avoid damage.

INSTRUCTIONS Point of use:

WARNINGS • It is essential that instruments are reprocessed as soon as is reasonably practical following use. Especially devices with long, narrow cannulas, hinges and blind holes, in order to prevent drying of adherent residues, traces of silicone oil, viscoelastics, tissues or drugs. • Stainless steel instruments must not be exposed for long periods of time to chlorides (e.g. physiologic saline solutions), this could trigger pitting corrosion. • Remove and discard any single use components. • If silicone oil is used in the surgical procedure, all silicone parts that come in contact with the silicone oil, should be discarded. • Medical waste is subject to local protocols and national or regional regulations. Use accessories to flush lumens when supplied with the instrument Process steps: 1. To prevent drying of soil, immerse instrument in cold tap water. 2. To remove external soil, brush exterior with soft bristle or single-use, lint-free cloth. 3. To remove internal soil, flush lumens of medical devices used for irrigation and/or aspiration with cold tap water in the dir ection of flow; at least 5 times using at least 10 ml in each case. 4. Rinse instrument under cold running water. Operate instruments with a mechanical function (like forceps and scissors) at least 10 times under running water. 1. 2. 3.

To avoid damage to instrument use protection cap when supplied with the instrument. To protect personnel from contamination, place instruments in a suitable container for transport to the decontamination area. To prevent drying of residual soil, instruments should be kept moist.

Preparation for decontamination:

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Disassemble the instrument when indicated in, and according to the additional instructions. Dispose all single use components when indicated in the additional instructions.

Cleaning: Automated

NOTE • When cleaning multiple products in one cleaning cycle ensure that the equipment maximum load is not exceeded. • Aluminum based instruments can discolour by alkaline detergents and solutions; this doesn’t influence the safety and effectiveness of the instrument • Do not use hydrogen peroxide on titanium instruments or on anodized surfaces in order to avoid discolourisation. • Wherever possible avoid use of mineral acids.

Containment and transportation:

Equipment: • Automated Washer Machine: device should be validated according ISO 15883-1, Use a high alkaline detergent (pH 10.0-11.0) for example Dr. Weigert Mediclean (concentration 0.5%). Process steps: 1. Remove the protection caps prior to cleaning and sterilization. 2. Place the instruments in suitable carriers such that they are not subject to excessive movement or contact with other instruments, and internal lumens are flushed during the cleaning. • The use of an ophthalmic rack is recommended. 3. A cleaning cycle with the following cycle parameters has been validated: • A cold water rinse cycle during 2 minutes, followed by draining; • A detergent cycle during 5 minutes at 55°C (131°F) for a high alkaline cleaner, followed by draining; • A water rinse cycle > 20°C (68°F) during 3 minutes using deionized water, followed by draining; • A water rinse cycle > 20 °C (68°F) during 2 minutes using deionized water, followed by draining. If instructions of the detergent supplier require adjustment of this specified process, effectiveness of cleaning should be validated. 4. When the wash programm is complete, it is recommended to visually inspect the instruments to ensure they are clean Drying: manual

Cleaning: Manual

WARNING • Immediately perform drying step after cleaning. Process steps: 1. Use a clean syringe to flush all lumen with air, or use filtered oil-free compressed air. 2. Wipe the instrument dry with a lint free non-abrasive cloth or dry using filtered oil-free compressed air. 3. Visually inspect instrument for moisture and repeat drying if any moisture is found. WARNINGS • Prevent the product from coming into contact with the sides of the ultrasonic container to prevent damage. • Do not process phaco handpieces in an ultrasonic cleaner. • Aluminum based instruments can discolour by alkaline detergents and solutions. • Avoid use of mineral acids and harsh, abrasive agents. Equipment: • Ultrasonic cleaner with fresh neutral pH cleaning solution in concentration as per cleaning solution instruction. For example Cidezyme (ASP) concentration 0.8%.

Drying: automated

Maintenance, Inspection and Testing:

WARNING • Immediately perform drying step after cleaning/disinfection. Equipment: • Automated Washer Machine, with drying program validated according ISO 15883-1. Process steps: 1. To prevent moisture on instruments after cleaning, a drying cycle should be included directly following cleaning and disinfection cycles. WARNING Defective instruments should not be used. In case of doubt regarding the status of your instrument, please contact the manufacturer. Maintenance, Inspection and Testing: 1. Prior to sterilization, carefully inspect instrument for possible wear or damage. This may include: distortion, dents, slack, burrs, cracks or corrosion. Use magnification if applicable. Pay special attention to joints, needles, tips, hinges, cutting edges etc. 2. If signs of damage are observed, discard instrument or contact DORC for repair possibilities. If a medical device is returned to DORC or the local representative, the medical device must be clean. 3. If applicable, assemble the instrument when indicated in, and according to the additional instructions. 4. Prior to reuse, the user should inspect the device to ensure that visible deterioration (such as corrosion or cracking) or mechanical deterioration (such as unexpected resistance with movable parts or loose parts) has not occurred. If any deterioration is detected the device should be discarded and not reused.

Packaging:

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Pack the instruments and medical devices in a protective tray suitable for sterilization, if applicable. Pack and seal in a peel pouch or complying to ISO 11607-1. Use a pouch suitable for the steam sterilization process used. For US only use a FDA cleared peel pouch. If you are unsure if the pouch intended for sterilization has been cleared by FDA, please check with supplier.

Sterilization:

WARNINGS • When sterilizing multiple products in one autoclave cycle ensure that the sterilizer’s validated load is not exceeded.

Sterilization:

Equipment: Steam autoclave: process should be validated according ISO 17665-1 Sterilization: 1. Sterilize the instrument according to one of the following minimum sterilization cycle parameters. Steam autoclaving gravity-displacement Sample configuration Cycle parameters

132°C (270°F) 15 minutes

Drying time

20 minutes

Steam autoclaving prevacuum (dynamic air removal) *

In peel pouch

In peel pouch 132°C (270°F) 4 minutes

135°C (275°F) 3 minutes 20 minutes

* in accordance with the recommendations of the Robert Koch Institute, the sterilization time shall be at least 5 minutes at 134C (273°F). This recommendation requires amongst others the cleaning to have been performed using an alkaline cleaning agent with a pH higher than 10. If an alkaline cleaning agent with a pH lower than 10 was used, the sterilization time should be extended to 18 minutes.

Note: The instructions provided above have been validated by the manufacturer of the medical device as being capable of preparing a medical device for re-use. Follow local guidelines and standards on reprocessing if applicable. It remains the responsibility of the processor to ensure that the reprocessing as actually performed using equipment, materials and personnel in the reprocessing facility achieve the desired result. This normally requires validation and routine monitoring of the process.